Manager, Validation Resume Sample
Anne Dickinson
13579 Lela Rest,
Los Angeles,
CA
+1 (555) 198 7410
Work Experience
Manager, Validation
11/2017
-
PRESENT
Phoenix, AZ
- Provide expertise, guidance and oversight for Validation efforts
- Develop, execute, sustain, and improve Validation systems to ensure compliance with FDA regulations/guidelines, ICH, ISO and other regulatory requirements
- Manage Validation Lifecycle for business including Change Control relating to Process, Equipment, Materials, etc
- Manage/oversee Validation group
- Recruit, train, develop, and mentor staff
- Responsible for the development and implementation of the Site Validation Master Plan
- Expertise to work with all levels of management, staff and internal departments including outside contractors and vendors, as applicable
- Provide expertise in the development, review, approval, and execution of validation documentation including, but not limited to: URS, FDS, DOE, FAT, IQ, OQ, PQ, and VQs
Senior Manager, Validation
04/2011
-
10/2017
Houston, TX
- Develop and maintain a requalification schedule for facilities, equipment and processes based on a risk assessment, current industry "best practices," and Regulatory requirements
- Develop and implement staff schedules to meet Validation timelines
- Responsible for the maintenance and implementation of the Akorn Amityville Validation Master Plan Schedules, including facility, equipment and process requalification
- Key support of the Change Control program for the facility
- Excellent working knowledge of cGMP requirements on validation methods and principles including ISPE, GAMP guidelines and FDA, CFR Part 11 Electronic Records and Signatures requirements
- Able to handle multiple, complex projects and work independently
- Provide validation direction to product development teams during product development
Validation & Verification Manager
10/2006
-
11/2010
Houston, TX
- Represent the consumer in assuring functionality, reliability, and safety
- Develops, plans, and executes product qualification testing needed to assure product function, reliability, safety, and compliance
- Create test plans that validate consumer claims, review test data, and statistically confirm claims
- Effectively able to drive needs of the function while operating as team member of cross-functional project teams
- Release Production Start Authorization on time for each project
- Act as validation reviewer for operation's SOP's with validation cycle parameters and possess ability to quickly address operations’ issues with equipment validated cycles
- Update and maintain validation SOP’s for conducting all validation work to include: sample preparation, sample collection, sensor calibration, and final report documentation packages
- Relevant experience in engineering, preferably in the pharmaceutical validation testing discipline
Education
Grand Valley State University
2001 - 2006
Engineer's Degree in Engineering
Professional Skills
- Excellent written and oral communication skill, good decision making skills and time management skills
- Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization
- Strong technical writing skills are required to author validation documentation
- Oversight of process validation, cleaning validation and equipment validation by working with appropriate internal departments
- Strong interpersonal and presentation skills for interacting with team members and
- Experience in silicon validation using functional and requirements-based validation methodologies
- Demonstrated knowledge and experience of manufacturing process validation
How to write Manager, Validation Resume
Manager, Validation role is responsible for validation, english, software, auditing, technical, protocol, negotiation, leadership, travel, training.
To write great resume for manager, validation job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manager, Validation Resume
The section contact information is important in your manager, validation resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Manager, Validation Resume
The section work experience is an essential part of your manager, validation resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous manager, validation responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manager, validation position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manager, Validation resume experience can include:
- Responsible for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information./automation validation
- Strong knowledge of aseptic process validation, drug product manufacturing process validation, cleaning validation, and equipment qualification
- Experience of SAS, SATA, PCIe, NVMe or similar interfaces and prior validation experience in this area at electrical and/or protocol level
- Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals
- Prior experience defining and developing FW functional validation strategies
- Excellent communication, writing and computer skills
Education on a Manager, Validation Resume
Make sure to make education a priority on your manager, validation resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, validation experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Manager, Validation Resume
When listing skills on your manager, validation resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical manager, validation skills:
- Good communication skills in French & English
- Experience in the industry with relevant experience in the areas of VLSI/ASIC design, verification, validation, project and people management
- Proven experience in validation or development of Cloud based solutions open source and/or proprietary
- Effectively work with cross functional teams (Product Management, SQA, Technical Operations) to ensure the validated state of the system is maintained
- Prioritize and coordinate the daily activities of the Validation Engineers and Technicians/Validation contractors
- Excellent oral and written communication skills and ability to tailor to technical individuals at all levels
List of Typical Experience For a Manager, Validation Resume
1
Experience For Senior Manager, Validation Resume
- Provide oversight of Validation department and Validation Processes
- Ensuring timely issue escalation to the Head of Operations Validation, Quality Assurance, and owning departments
- Provides oversight of Qualification and Validation Processes including: Equipment, Facility, Media, Cleaning, Sterilization, Computer Systems and Shipping
- Experience in measuring hardware performance against requirements -- timing, hw protocol performance measurement
- Experience in an engineering or manufacturing field
2
Experience For Validation Engineering Manager Resume
- Experience in measuring performance and latency of command/data round trip
- Represent Validation and Emergent during FDA and other regulatory agency inspections
- Power Management - Microcontroller power management functional validation
- Investigate and close-out exception reports and non-conformances associated with validation studies
- Experience in the medical device/IVD industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods
3
Experience For Validation & Verification Manager Resume
- Experience in both front room and back room audit support
- Working knowledge of high level language C, any object-oriented language and scripting language
- Providing leadership and direction to the Requalification specialists while embodying the principles of the Sanofi Global Leadership Model
- Facilitating and providing support to the continuous improvement and automation projects in an environment of rapid change
- Assist development and manufacturing engineering in designing, performing, and improving verification tests
- Evaluates new projects or existing equipment modifications, in terms of qualification and calibration needs, regarding the quality impact
- Approves the resolution of discrepancies encountered during protocol execution
- Assist in continuous improvement for the department by evaluating systems to improve functionality and efficiency
4
Experience For Engineering Group Manager Validation Resume
- Collaborates with R&D during technical transfers to integrate process analytical technology (PAT) and system controls within the Quality by Design framework
- Early program engagement with stakeholders to scope out the project including PLC Product life Cycle expectations, drive PLC check points
- Tracks execution progress against program schedule, track sightings and blocking issues resolution
- Provides ongoing program status reviews to ATV Staff
- Adaptable to fast-paced, dynamic work environment with shifting demand
- Identify differences between ISO and FDA requirements and their applicability to products targeting different markets
5
Experience For Manager for AML Scenario Management & Validation Team Resume
- Work with scientists, technicians, engineers, marketing, and project management to deliver commercial and internal genetic analysis systems
- Knowledge and working application of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP requirements
- Knowledge of Agile software development, and software testing methodologies
- Facilitate test sample allocation requests, tracking of S/N and distribution to DAE team members
- BS in Engineering, Computer Science
- Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment
- Identify critical issues from varying points of view and make timely quality decisions
- Communicates metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations
- Knowledge of PCI, SAS, SATA, DDR, I2C, SPI or UART standards
6
Experience For Manager Product Expert Validation Product & Process Resume
- Select bidders, award and administer contracts involving for consulting, laboratory, and process validation engineering services. Prepares and defends five-year plans and annual budgets for the department by assessing manpower and capital needs
- Participates in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance as the validation representative on engineering project teams. Develops and maintains a plant wide change control system to review, authorize and document changes to validated systems
- Represents the Company as an active participant on internal (GQD) and external (ISPE/PDA/PMA) professional committees establishing policy guidelines relating to validation issues
- Coordinate resources and personnel to achieve company and department goals
- Pre-approve and post-approve qualification protocols
- Execute protocols and aseptic process simulations
- Approves qualification summary reports
- Provide guidance to the validation team in establishing policies, procedures, and strategies consistent with cGMP, International guidance, and the Company’s Quality Programs
7
Experience For Manager, Validation Engineering Resume
- Assist in the design and implementation of facilities and equipment qualification and validation protocols
- Work with manufacturing to design and implement cycle development studies in areas such as sterilization and product contact cleaning assessment validation studies
- Provide expertise in the development, execution and review of validation protocols
- Develops and maintains effective relationships with internal and external customers, regulators, and other stakeholders
- Demonstrated ability to execute and organize and lead efforts to influence organizational change
- Demonstrated ability to build and grow a team is highly desired
- Experience with a high volume, consumable production process highly desired
8
Experience For Manager, Actuarial Validation Unit Resume
- Participate in annual site audits as needed
- Develop and maintain a requalification schedule for facilities, equipment and
- Responsible for site Qualification and Validation Plans that include process validation, packaging validation, cleaning validation, equipment qualification, utilities and facilities qualification, and computer system validation
- Develops, implements, integrates, and sustains validation systems to enhance compliance in accordance with ICH guidelines Q8, Q9, and Q10
- Creates and implements changes in the Qualification programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base
- Manages the qualification activities associated with all Quality Investigations
- Determine FDA’s current regulatory and enforcement policies regarding process validation of drug manufacturing for domestic and foreign sites and implement procedures accordingly
9
Experience For Validation Test Manager With Life Sciences Domain & Opsm Resume
- Participate and represent ATV in various programs forums, ex. train release planning, train feature support, POWG, VST, Mission control, PVST, etc represent ATV as needed
- Actively drive adaptation of convergence and standardization of methodologies and processes during execution
- Ownership of the program H/W and resource needs Boards, Silicon, units, Test cards, thermal infrastructure, resources, BTI, etc
- Manage program health indicators, communicate and escalates to ATV IP managers and external teams as necessary
- Managing and developing the performance of direct reports by setting clear "SMART" goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance
- Partnering with a Manufacturing Scheduler to ensure equipment is available to meet the Requalification schedule, while holding supervisors and specialists responsible for executing protocols "on time" while maintaining compliance to all safety and quality regulations
- Manages the computer validation program
- Oversee and occasional assistance of execution of Validation protocols
- Oversight of the equipment and facility validation functions
10
Experience For Senior Manager, Computer System Validation Resume
- Ensuring that appropriate levels of trained resources are available to meet the Requalification schedule
- Ensures the development, issuance, and maintenance of the Requalification schedule (annual and three month look ahead)
- Lead validation team in developing, managing, and maintaining full SDLC validation deliverables for Medpace’s regulated computer systems, including validation & test plans, User Requirement & Functional Specifications Functional & User Acceptance testing, Trace Matrices, and Validation Summary Reports
- Scheduling, oversight and performance of validation activities at AMRI
- Manages and consults on cleaning validation
List of Typical Skills For a Manager, Validation Resume
1
Skills For Senior Manager, Validation Resume
- Strong statistics and data analysis skills are required
- Demonstrated experience with validation methodology in a regulated industry, preferably in a GMP environment
- Strong experience in Validation/Qualification and computerized systems
- Good English language and negotiation skills
- Experience in managing team or around 8 to 10 engineers in validation and resolving complex problem
- Familiarity with validation tools and processes, including temperature mapping and use of Kaye Validator
- Highly desirable to have prior experience with developing and maintaining department budgets
- Experience developing multiple validation plans and executing protocols
2
Skills For Validation Engineering Manager Resume
- Represent validation during agency and client audits (as needed) on matters pertaining to equipment and facilities validation responsibilities
- Familiarity with pre-Si verification methodology, post-Si validation concepts, test plans, post-Si validation environment, and test writing/debug
- Lead the validation team to validate product hardware and firmware are capable of meeting all product specs
- Hands-on experience in Commissioning, Qualification, and Validation activities (CQV) to include
- Validation experience of equipment cleaning methodologies
- Experience working in Computer Systems Validation
- Work well within a cross functional team of varying skillsets
3
Skills For Validation & Verification Manager Resume
- 10-15yrs experience with increasing responsibility in project management of life sciences, biotech or other FDA regulated validation projects
- Solves qualification issues using critical analyses skills; develops sound, reasoned solutions and recommendations
- Demonstrated strong analytical problem solving (CAPA)
- Solid understanding of 21 CFR Part 11, GCPs and principles of computer validation
- Work naturally well in a team environment, exhibit strong team leadership, and provide mentoring to validation engineers
- Provide Quality support for execution of validation / qualification activities according to schedule and priorities
- Strong experience in analytical and/or microbiological testing
- Ensures that supporting documentation and test results are formally recorded and reported; resolutions are implemented effectively
- Validation experience in the pharmaceutical industry, or equivalent
4
Skills For Engineering Group Manager Validation Resume
- Team player: ability to interact effectively with team and customer
- Experience with validation aspects of facility start-up, redesign/retrofit, and expansion is desired
- Experience in pre and post silicon validation, board developments
- Previous experience in the review of validation (process, IOPQ) protocols and reports is required
- Industrial experience in the area of validation within Pharmaceutical/ BioTech industry
- Experience with validation/qualification in a GMP environment
- Experience with Good Documentation Practices
- Hands-on experience with the validation of clinical applications in the Life Sciences such as EDC, CTMS, eTMF, TMS, AERS and/or IVRS
- Experience in a validation related role
5
Skills For Manager for AML Scenario Management & Validation Team Resume
- Support the validation team party in achieving validation targets as per defined time lines
- Oversee, review and approval of the site Validation Mater Plan and Validation Project Plans
- Reporting validation status to Director and Project Management Team
- Developing and delivering comprehensive validation plan and leading its detailed implantation
- Coordinate that revalidation of manufacturing and filling cleaning processes (where required)
- Solid understanding of manufacturing processes in medical device manufacturing
- Responsible for tracking, monitoring and controlling validation process
6
Skills For Manager Product Expert Validation Product & Process Resume
- Leads and supports initiatives ensuring department and site Validation Compliance including training, communication forums, continuous improvement
- Three to eight years relevant work experience performing in a demanding/schedule driven R&D environment,
- Experience in vaccine production including knowledge of new production technologies, in particular Packaging
- Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control is required
- Previous experience working with FDA (CBER) and participating in regulatory agency inspections
- Serves as a subject matter expert for process, packaging, and cleaning qualification and validation systems for site regulatory inspections
- Estimate timelines and budgeting for validation engineering development efforts
- Experience in manufacturing, quality assurance or engineering in an FDA regulated environment
7
Skills For Manager, Validation Engineering Resume
- Manage the activities of several functional groups of the Validation Department consisting of supervisory, professional, and technical employees
- Strong working knowledge of ISPE baseline, EU regulation, ICH and CFRs is required
- B.Sc. or M.Sc.in Chemical and or Biological Sciences or equivalent. At least 7 years of related work experience in QC or a test R&D setting
- Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500
- Provide guidance and support during validation development activities for all team members
- Updates, reviews, and approves area procedures to ensure compliance with Good Manufacturing Practices
- Report broadly through the organization on validation activities and instrument manufacturing audit readiness
- Managing a mid-size (6-10 FTE) team with demonstrated ability to coach, mentor, develop and discipline
- Knowledge and working application of Validation Principles, guidelines and industry practice
8
Skills For Manager, Actuarial Validation Unit Resume
- Experience/understanding of cGMP, ICH Q9 Quality Risk Management is desired
- Proven ability to drive collaboration and influence team members from broad engineering disciplines
- Experience using MS Project to manage activities and interdependencies to track progress and resolve critical path issues
- Demonstrated holistic thinking and actions within a matrixed organization
- Lead role within Project teams representing Validation. Measure and report project execution progress
9
Skills For Validation Test Manager With Life Sciences Domain & Opsm Resume
- Represents Validation and Emergent during FDA and other regulatory agency inspections. Interacts with contract, corporate, and governmental agency auditors
- Develops Validation systems, reviews commissioning and qualification reports for major projects
- Participates in review of contract negotiations for potential customers (specific to review of sections pertaining to Validation)
- Designs, implements, and documents validation for manufacturing processes, equipment, and systems for multiple business units
- Responsible for documentation preparation, review and execution for aseptic processes, process validation, equipment, utilities, and cleaning procedures
- Acts as the key liaison between Company and clients regarding validation issues
- Track and summarize validation activities and inform product development teams of progress, issues and schedule changes
- Lead the validation team to confirm correct system level functionality of ASICs, FPGAs, system-level assemblies and test boards
10
Skills For Senior Manager, Computer System Validation Resume
- Define standard validation processes that align with Silicon Development processes and Product Development processes
- Establish schedule templates for the validation activities such that new Product Development schedules can be defined and become predictable
- Demonstrated knowledge of cGMP compliance
- Experience in test plan creation
- Strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry
- Strong knowledge on GxP systems and business processes supporting Clinical, Regulatory, and Drug Safety & Pharmacovigilance
List of Typical Responsibilities For a Manager, Validation Resume
1
Responsibilities For Senior Manager, Validation Resume
- Effectively lead a team and work independently, within prescribed guidelines, or as a team leader or member
- Lead and support initiatives ensuring department and site Validation Compliance including training, communication forums, continuous improvement
- Manage validation team in prototype SOC bring up and HW/FW integration while working together with FW and IC engineers
- Determine and coordinate the training needs of employees directly involved in the functions associated with Equipment and Facilities Validation
- Experience with electrical/system engineering and interest in project management, especially
- Manages the process validation program
- Ensure validation program meets requirements of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP
2
Responsibilities For Validation Engineering Manager Resume
- Self-motivated with a strong desire to drive for/deliver results
- Coordinate in all facilities, equipments and operations at site are validated (DQ, IQ, OQ, PQ) in line with the regulatory and corporate requirements
- To support in the preparation of status or update of validation activities for Site Quality Councils meeting
- Manage all validation activities and projects with departmental managers
- Ensure execution of validation activities are done to state and federal regulatory requirements, Herbalife and/or other applicable regulations and standards
- Ensures validation approaches are aligned with relevant guidance documents and current industry best practices
- Determines the causes of measurement errors as related to validation and calibration and present solutions to resolve them
- Experience with RABS and isolator technology is highly desirable
- Directs and provides expert knowledge in the day-to-day function of Validation
3
Responsibilities For Validation & Verification Manager Resume
- Manage, identify, hire, and develop team to support validation activities. Manage continued growth, development, and retention of the team
- Coordinate all equipment and facilities validation activities as related to plant operations
- Review and approve all protocols, reports and studies as prepared and conducted for equipment and facilities validation
- Perform validation assessments for all equipment and facilities related change controls
- Working knowledge of cGMPs, FDA regulations, ICH Guidelines for Manufacture of APIs, and familiarity with the European Community Guidelines for GMP
- Managing the lab budget
- Test Automation via in house tools using Java & Scripting language
- Able to lead others with and without direct reporting authority
4
Responsibilities For Engineering Group Manager Validation Resume
- Active leader in driving value stream performance (support of WO, CC, CAPA and NCE processes). Able to drive positive change cross functionally
- Communicate metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations
- Responsible for enhancing a lab setup and purchase of lab equipment
- Assist with the development and tracking of the department budget
- Manages the equipment/facilities qualification program
- Manages the plant change control system
- Participation on customer specific project teams as needed
- Participate in regulatory and client audits
- Drive staff results by communicating job expectations, planning, monitoring and appraising job results, coaching and counseling employees, recognizing performance issues and driving improvement, developing, coordinating and enforcing systems, policies, procedures and productivity standards
5
Responsibilities For Manager for AML Scenario Management & Validation Team Resume
- Establish strategic goals by gathering pertinent business, financial, service and operations information, choosing a course of action, defining objectives, and evaluating outcomes
- Maintain staff by recruiting, selecting, orienting and training employees; maintaining a safe, secure and legal work environment; developing personal growth opportunities
- Knowledge and working application of FMEA and Risk Analysis
- Proven ability to lead in a continuous improvement environment, identify the end state and lay out a step-by-step plan for attainment while messaging broadly achievable timelines
- The ability to discuss technical topics with non-technical people is strongly desired
- Lead and execute (as needed) the validation activities for Veeva’s general releases, hot-fixes, product re-baselines for Clinical applications
- Provide technical expertise, interpretation and direction in regards to computer validation, GCP regulations and other quality requirements
6
Responsibilities For Manager Product Expert Validation Product & Process Resume
- To ensure timely delivery to meet pre-scheduled release dates
- Work with Product Managers to ensure requirements/specifications are defined in a clear, compliant, testable format
- Identify and log issues found during validation execution. Work closely with Product and SQA teams to identify and prioritize issues early on and track validation incidents to closure
- Experience in regulated life science validation role
- Independent pre and post execution review of validation test scripts
- Supports change control as validation technical resource and ensures timely completion of required tasks
- Perform validation impact analysis and risk assessments in conjunction with product teams
7
Responsibilities For Manager, Validation Engineering Resume
- Strong project management background in new product development (5+ yrs)
- Communicate project status to stakeholders (functional managers, program managers, Validation engineers, project engineers…)
- Strong project management background in new product development (3+ yrs)
- Coordinates with cross-functional teams to design and execute test protocols
- Develop and maintain a schedule of key DAE activities with interdependencies with the broader product development schedule
- Ensure on-time exchange of information between DAE and various organizations of a development team (Integrity database, design reviews, FA and CA…)
- Lead discussions to track and resolve project risks and issues
- Oversee and be accountable for JDM's schedule and status of JDM's DAE related activities
- Program management certification desired but not required
8
Responsibilities For Manager, Actuarial Validation Unit Resume
- Development of Validation systems, review of commissioning and qualification reports for construction and validation of a new large scale manufacturing facility
- Maintain Validation Master Plans to ensure compliance with regulatory requirements and current industry practices
- Provide oversight of process, cleaning, equipment, facilities, utilities and process automation in support of product manufacturing for commercial manufacturing
- Provide leadership, expertise and management to validation personnel
- Champion and lead Continuous Improvement within and outside of the team around validation activities
- Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements
- Validation lead and approver in authoring or reviewing of various compliance documentation such as deviations, CAPAs, change controls, technical study protocols
- Maintain on-time completion of all re-qualification activities by the team
- Establish and maintain an environment that stresses and encourages the core culture values and teamwork
9
Responsibilities For Validation Test Manager With Life Sciences Domain & Opsm Resume
- Evaluate and manage skills and development needs of individuals and teams, manage the IPMP for direct reports and mentor associates to facilitate professional and departmental growth
- Translate corporate policies to site specific procedures and practices
- Define metrics that exhibit productivity and throughput in functional area
- Prepare trend reports and summaries for routine management review
- Maintain metrics within predetermined limits
- Participate/Support interdepartmental/site leadership and operational excellence initiatives
- Develop FDA inspection response strategies and coordinated response and gap analysis teams
- Lead and influence cross organizationally with and without authority; able to interface with interplant, departmental and divisional groups
- Ability and willingness to work in a global cross-functional project environment
10
Responsibilities For Senior Manager, Computer System Validation Resume
- Occasional international travel (1-3X per year) required
- Working in cross-functional teams responsible for process improvement and process compliance; bringing the regulatory and corporate perspective of validation and systems applications to the GMS
- Investigate, document, and resolve protocol deviations in a timely manner
- Ensure that documentation is accurate and deviations are properly addressed
- Uses mathematics to solve measurement related problems as well as to derive and interpret specifications
- Oversees document deviations, system failures, investigations, and corrective actions
- Serves as subject matter expert for regulatory and client audits
- Review, revise and develop Standard Operating Procedures (SOPs) applicable to equipment and facilities validation and assist in the review and development of plant-wide SOPs
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