Validation Engineer Resume Sample
Alanis Moore
43240 Dorcas Union,
Houston,
TX
+1 (555) 811 6414
Work Experience
Senior Validation Engineer
05/2018
-
PRESENT
New York, NY
- Responsible for document management including scanning and archival of validation documents
- Works with operations and facilities to develop SOP’s that meet all applicable regulatory requirements
- Validation, planning, coverage definition, test content creation & automation, triage/debug of specific validation function related to USB, type C & IO/ storage sub system across platforms & product lines
- Attends subsystem VST, Ingredient/ Platform Sysdebug on need basis
- Works with peer orgs for feature enablement, system level dependencies, coverage analysis/review & sighting management
- Content development, reviews, automation, coverage optimization, execution before deployment, analyze test content effectiveness and competitive feature/ UX analysis
- Continuously drives improvement in validation methods, tools, UX, cycle time and content optimization
Validation Engineer
10/2013
-
01/2018
Dallas, TX
- Identify and recommend corrective actions to observed test issues
- Participate on teams designing, building and implementing new actuation test lab equipment, software and data collection equipment
- Work directly with Applications Engineers and Technicians to ensure timely and
- Participate on teams designing, building and implementing new actuation test lab
- BSEE with at least 4 years industry experience
- Proficient in using the lab equipment’s like Oscilloscopes, spectrum analyser, Thermal chambers etc
- Develop protocols using engineering experience and statistical process controls for new products and equipment that thoroughly test failure modes in order to ensure robust operation during production
- Assist with multiple cross functional projects from development through release to production. Projects include new facilities startup, packaging line FAT and qualifications, and new product launch
- Coordinate activities in support of the Validation Department priorities with the assistance of the department manager
Validation Engineer Co-op Student
07/2008
-
09/2013
Dallas, TX
- Experience in a Technical/ QA/ Validation Role within the pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes
- Design and attend F.A.T. testing at vendor facility, as required
- Operate Thermal Mapping Equipment
- Have the ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise
- Train other Validation personnel
- Develop the plan for writing Test Orders and any post-test, detailed photos, Materials Lab requests to document the sample’s material & its failure mode, or required NVH qualification
- Coordinate and execute complex DVP and PVP test plans
- Work directly with Applications Engineers and Technicians to ensure timely and accurate test results
- Generate test reports including expert analysis and recommendations
Education
Missouri University of Science and Technology
2002 - 2007
Engineer's Degree in Engineering
Professional Skills
- Excellent organizational skills and interpersonal skills; excellent verbal and written communication skills
- Strong validation skills with demonstrated knowledge within the areas of equipment / process /computer system validations and quality assurance
- Good interpersonal skills, and accountable with excellent verbal and written communication skills
- Strong organizational skills, including being able to plan and prioritize tasks
- Experience with commensurate skills in managing the testing and/or validation of consumer products
- Demonstrated computer skills and experience using Microsoft Office 365 required
- Strong communication skills (oral & written) and demonstrated ability to communicate with a high level of technical understanding
How to write Validation Engineer Resume
Validation Engineer role is responsible for technical, interpersonal, organizational, computer, analytical, english, programming, validation, software, leadership.
To write great resume for validation engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Validation Engineer Resume
The section contact information is important in your validation engineer 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 Validation Engineer Resume
The section work experience is an essential part of your validation engineer 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 validation engineer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular validation engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Validation Engineer resume experience can include:
- Good communication skills and good planning & organisation skills
- Excellent verbal, written skills and oral presentation skills
- Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans
- Individual with has a strong balance between Engineering and IT skills. The role requires a solid understanding in each of these domains
- Excellent writing skills and previous experience preparing IQ/OQ/PQ/PPQ documentation
- Demonstrated ability to be a self starter, excellent documentation practice, and troubleshooting laboratory instruments skills of high levels of complexity
Education on a Validation Engineer Resume
Make sure to make education a priority on your validation engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your validation engineer 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 Validation Engineer Resume
When listing skills on your validation engineer 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 validation engineer skills:
- Strong software background, including experience with Linux drivers and/or kernel; Solid experiences in embedded software validating
- Strong ability to manage multiple priorities, good oral and writing skills and work independently
- Strong problem solving skills, ability to work independently, excellent organizational skill s
- A team player with good organizational and/or planning skills and solid verbal and/or written communication skill
- Good communication skills. Ability to communicate effectively with scientists, engineers and software developers
- Direct validation experience (authoring and executing validation protocols) with at least 1 year of cleaning validation experience
List of Typical Experience For a Validation Engineer Resume
1
Experience For Senior Validation Engineer Resume
- Be a team player with good interpersonal skills; able to work independently, multitask effectively
- Associate Validtion Engineer Possess strong project management, organizational, analytical, computer, writing and communication skills
- Experience in ASIC Iogic verification and strong software skills
- Strong team and collaboration skills with excellent written and oral communication
- Experience - Desired: Demonstrated experience and proficiency with cGXP, ICH and PIC/S. Experience with regulatory and/or third party audits
- Experience with validation (especially cleaning, automation and equipment validation), FDA experience and scientific knowledge of the industry
- Demonstrated results in leading team communication, resolving team conflict, and leading with interpersonal skills
2
Experience For System Validation Engineer Resume
- Perform validation activities described in validation protocols including thermal studies, cleaning, equipment and utilities validation
- Excellent SW development, debugging and testing skills in C/C++
- Applied technical experience preferably with validation experience in pharmaceutical manufacturing and packaging
- Excellent interpersonal and communication skills, both verbal and written, are required. Special emphases on technical writing, requiring only moderate edits
- Experience with manufacturing engineering or validation experience
- Learn basic GMPs (Good Manufacturing Practices), GEPs (Good Engineering Practices) and GDPs (Good Documentation Practices)
- Prior experience developing FW for multicore SoC or for validation purposes including RTOS/Threadx
3
Experience For Component Validation Engineer Resume
- Self-directed and team oriented with demonstrated program management and problem solving skills
- Excellent interpersonal, communication (written & oral) & technical report writing skills
- Demonstrated experience leading equipment validation processes
- Proven communication and organizational skills for global working
- Exhibits expertise in product design and validation skills, to make sure all developing
4
Experience For Quality Validation Engineer Resume
- Highly effective verbal and written skills, including technical authorship
- Core competency in Linux OS, strong analytical & problem solving skills
- A highly structured working-style paired with excellent documentation skills
- Assist in the training of and/or direct the efforts of less experienced Validation Engineers and Validation Technicians
- Have good programming skills in C and/or Python,
- Excellent interpersonal, communication & technical report writing skills
- Responsibility for Validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports
- Effective resource finding skills in a highly collaborative environment
- Strong independent work skills to meet established deliverables
5
Experience For Analog Validation Engineer Resume
- Strong computer skills are also required
- Strong data analysis skills and a hands-on technical curiosity
- Develop Validation plans for small to medium size validation projects and write qualification/validation protocols, execute protocols and author reports
- Effectively engage with customers to resolve technical challenges and create a positive experience
- Solves qualification and cleaning validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations
- Excellent communication and problem solving skills,
- Participate in system validation team as technical validation representative. Reporting on key validation progress and issues
- Excellent organizational, analytical, and problem solving skills needed
- Strong technical knowledge and experience with pharmaceutical process, sterilization, and cleaning validation as related to sterile products
6
Experience For Validation Engineer MI Resume
- Possess strong project management, organizational, analytical, computer, and writing and communication skills
- Good command and presentation skills of both written and spoken English
- Very good English skills, written & spoken
- Excellent written communication and organizational skills required. Manufacturing computer systems knowledge highly desirable
- Effective communication skills to work in a collaborative manner with test operators
- Able to work successfully in a deadline-driven, fast paced environment and effectively multitask multiple priorities in a team-oriented environment
- Proven competence in Equipment Validation and Computer Systems Validation
- Excellent oral, written and interpersonal skills necessary
7
Experience For RF System Validation Engineer Resume
- Remain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices
- Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor
- Strong lab and measurement skills: oscilloscopes, bench supplies, multimeters, logic analyzers, spectrum analyzers
- Good documentation and data presentation skills
- Strong communication skills, both verbal and written; ability to work and interface with all levels of the organization
- SAS,SATA, PCIe, NVMe or similar interfaces knowledge and prior validation experience in this area at electrical and/or protocol level
- Developing planning and program management skills
- Ensuring the quality of facility systems (validation): writing protocol and test cases for validation
8
Experience For Battery Validation Engineer Resume
- Liaising with design team leaders to ensure that all required documentation and inputs have been received prior to commencing integration/validation
- Working Experience in Validation in the biotechnology/pharmaceutical industry and/or academic laboratory setting
- Programming and Computer skills : VBA, LabView, C, C#…
- Programming and debug skills
- Experience with Cleaning Validation including swabbing and rinse sampling
- Demonstrated understanding and use of statistical methods in experiment design, sampling, data analysis, validation, and process monitoring
- Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements
- Good understanding of software design and development cycle. Good understanding of algorithm testing best-practices is desired
- Engineering experience required or 4 years engineering experience required with a MS in engineering
9
Experience For RF Systems Validation Engineer TX Resume
- Facility, equipment, and/or cleaning validation experience in a cGMP manufacturing setting
- Experience in performing validation activities, integration testing, performance testing
- Good understanding of Ethernet and TCP/IP protocols and hands-on experience with switching and routing devices
- Provide planning and scheduling support to projects while defining validation scope of work, resources, and duration to meet site-wide validation goals
- Aides in troubleshooting/impact assessment for atypical conditions during validation runs/validations
- Experience implementing/executing a Process Validation Program
- Five to seven years’ experience leading validation protocols in an FDA/GMP compliance setting
- Administer a change management system for validated equipment, automation, utilities, cleaning validation, process monitoring and facilities
10
Experience For Connected Eco System Validation Engineer Resume
- Experience validating and qualifying, but not limited to Utilities, Distillate Systems, Syringe, Vial and
- Experience writing or executing validations
- Good command and hands on experience on PERL, Python scripting, SNMP interfaces , HTTP REST API testing
- Assist validation engineers in testing/validating telecom devices in the lab
- Experienced leader in managing testing/validation teams
- Prepare and setup validation testing equipment and prepare equipment for qualification/validation testing
- Perform equipment, aseptic processing, steam sterilization, cleaning validation and process validation and their associated control systems
- Validate new and revalidate as appropriate existing equipment used in Pharma/OTC/Cosmetic manufacturing
List of Typical Skills For a Validation Engineer Resume
1
Skills For Senior Validation Engineer Resume
- A strong analytical mind with first-rate problem solving skills Healthy paranoia for bugs and a strong sense of quality
- Excellent communication skills and strong fluency in English, both written and oral is essential
- Skills and experience - at least 2 years experience in relevant fields
- Strong debug skills in relevant experience
- Quality assurance or related experience and demonstrated leadership skills
- Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make logical decisions based on guidance from management
- Strong and diverse validation skills
- Programming experience in C/C++ including code triage and debugging skills
- Highly motivated, curious, and have good lab skills proper tool use, detailed note taking, and be keenly interested in finding and resolving silicon failures
2
Skills For System Validation Engineer Resume
- Experience in process validations – writing protocols, performing validations and compiling final reports
- Excellent programming skills in C/C++ and scripting languages like shell/python
- Experience with manufacturing engineering or validation experience
- Hands on validation experience in developing validation documentation and field execution
- Solid instrument calibration and troubleshooting skills
3
Skills For Component Validation Engineer Resume
- Demonstrated experience with cleaning validation and requalification of equipment
- Strong leadership skills driving self and organization to improve performance
- Demonstrated problem solving (CAPA) and risk assessment skills and the ability to adapt to new regulatory requirements
- Proven skills in providing direction to contractors and consultants
- Experience in validation, preferably on the CPU including experience in the area of test bench development
- Demonstrated competence in Computer Systems or Automated Systems Validation and awareness of 2 or more elements of validation including but not limited to
- Excellent organizational skills and problem solving abilities
- Good debugging skills, ability to analyze problems, diagnose root cause and apply corrective actions, able to create new test methodology for new technology
4
Skills For Quality Validation Engineer Resume
- Relevant validation experience in any of the following fields Wireless SoC / System validation RT/ Embedded systems
- Strong knowledge & prior working experience in C++ , C
- Experience:3 yrs in GMP-regulated industry, preferably medical device or pharmaceutical, 2+ years experience performing instrument validations
- Needs to have good programming skills on C or Python
- Good oral communication, organizational and planning skills
5
Skills For Analog Validation Engineer Resume
- Excellent communication skills- Team-player- Self-driven and entrepreneurial way of working
- Strong RF and high-speed digital (>10Gbps) measurement and debug skills
- Excellent cross functional team and leadership skills
- Excellent written and oral communication to include accurate and legible documentation skills
- Excellent verbal and written communication skills, able to present information to all organizational levels
- Excellent written communication skills are essential
6
Skills For Validation Engineer MI Resume
- Use strong verbal & written communication skills
- Strong software skills preferably C++ / hardware simulator development
- Excellent communication skills with the ability to read, write and speak English
- Good communication skills in English and willingness to work in a competitive team environment in multiple geo-locations
- Excellent interpersonal skills to contribute as a great team player
7
Skills For RF System Validation Engineer Resume
- Strong interpersonal, leadership and communication skills both verbal and written are required for the execution of this role
- SAS, SATA, PCIe, NVMe, DDR4 or similar high speed interfaces knowledge and/or prior validation experience
- Effectively work on project teams and build strong working relationships
- Effective oral written communication skills are required
- Demonstrated skills in quality & compliance
- Validation experience (instrument validation - HPLC)
- Solid data analysis, manipulation, summary and presentation skills
8
Skills For Battery Validation Engineer Resume
- Excellent oral, written and interpersonal skills in a high pressure environment
- Strong programming and debug skills
- Strong Python, C/C++ skills
- Strong leadership and communication skills is a requirement
- Validation experience in Computer or Automated systems validation in a Pharmaceutical or related industry
- Demonstrated ability to work on multiple projects effectively
- Demonstrable experience in Quality Operations/Validation of equipment, utilities and facility validation
- Experience in pharmaceutical validation, or equivalent industry experience
9
Skills For RF Systems Validation Engineer TX Resume
- Excellent Interpersonal Skills, team-oriented
- Proven ability to communicate effectively with peers and counterparts
- Strong leadership and project management skills
- Experience with validations of USP water, controlled environments or equipment validations
- Good verbal and written communication skills are required, both in English and Spanish
10
Skills For Connected Eco System Validation Engineer Resume
- Professional Skills, Qualifications and Experience
- Strong experience in validation and test of robotics systems (or closely related industry)
- Demonstrated effective project management performance experience
- Demonstrated superior communication, teamwork and organizational skills
- Experience with validations of USP water, controlled environments or equipment validations in a regulated environment
- Excellent time, task, and self-management skills
List of Typical Responsibilities For a Validation Engineer Resume
1
Responsibilities For Senior Validation Engineer Resume
- Proven technical troubleshooting and problem-solving experience with a passion for learning technologies- 3-5 years applicable experience
- Experience in process validations – writing protocols, performing validations and compiling final reports
- Strong written communication skills for translating technical knowledge into detailed product set up and operating procedures during each phase of a test
- Excellent Linux software development, testing and debugging skills in C and/or C++
- Excellent knowledge in IC validation methodologies and experience in conducting test and measurements for various timing/current/voltage parameters
- Communicate effectively with product owners, validation partners and managers regarding issues, stability, and general quality
2
Responsibilities For System Validation Engineer Resume
- Strong technical writing skills and a proficient knowledge of MS Office products
- Experience in manufacturing, equipment maintenance and supervision; awareness of products characteristics, analytical methods validation, process validation
- Strong problem-solving skills to find solutions to problems quickly and accurately
- Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed
- Running tests and collecting data and effectively communicating the results to product engineers
- Devising and compiling a wide range of validation documentation, including validation plans, user requirements, design specifications, IQ, OQ and PQ protocols
- Programming skills in one of the following: C, JAVA, PERL, PYTHON
- Seeking a Validation Engineer with agricultural or mechanical experience
- Demonstrated technical fluency in the validation disciplines i.e. equipment, automation, manufacturing, packaging, cleaning
3
Responsibilities For Component Validation Engineer Resume
- 3 yrs in GMP-regulated industry, preferably medical device or pharmaceutical, 2+ years experience performing cleaning, automation and instrument validations
- Implement test plans for validation, as well as coordinate the implementation or scheduling of validation testing with affected departments and personnel
- Reviews cleaning development test records for accuracy and compliance with the company cleaning validation program and Good Documentation Practices (GDP)
- Good understanding of ISO 13485 requirements relating to product realization and process validation
- Work related development experience, including experience in the following areas
- Strong working experience in C/C++ programming
- Proven ability to demonstrate analytical capabilities (including modeling, simulation, statistical analysis, analytical design tools, etc.)
- Min 5 years of related experience in Medical Device quality system management, including experience working under Change Control and Design Control
4
Responsibilities For Quality Validation Engineer Resume
- Experience executing validation and commissioning/qualification studies (IQ,OQ,PQ)
- Experience writing commissioning/qualification/validation protocols and reports
- Experience developing products or validating product performance
- Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ)
- Experience in validation or engineering in a biopharmaceutical manufacturing environment
- Experience performing IP and/or SoC functional validation using System Verilog
- Experience in Python scripting development under Eclipse platform; Experience in Linux scripting language like shell script, Perl etc
- Experience in RF testing / validation, debugging of the wireless systems and test development
- Experience/Knowledge of C, C++ programming languages (strong Data Structures and Algorithms theory) and scripting Language such as Tcl/Tk
5
Responsibilities For Analog Validation Engineer Resume
- Three 3 to ten 10 years of related experience in Validation / Quality / Engineering in an FDA/cGMP compliant manufacturing environment is required
- Demonstrated understanding of the software development lifecycle, associated validation concepts, and knowledge of governing industry standards is required
- Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator
- Organize engineering training of the product design and validation skill for the team member
- Proven record of completing equipment, process, software, test method and/or cleaning validation
- Experience in other areas of Validation (cleaning, sterilization, shipping, process, equipment) also highly desirable
6
Responsibilities For Validation Engineer MI Resume
- Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, and Process Validation
- Relevant experience in pharmaceutical validation testing discipline
- Use skill and professional experience (with a full understanding of industry practices) to develop procedures
- Assist in preparing annual site Master Validation Plans and annual site Validation/Qualification reports
- Experience the pharma environment working with the validation and qualification of equipment, utilities, facilities and IT systems
- Maintain up to date knowledge of validation requirements, practices and procedures and instruct other members of the site participating in validation studies
7
Responsibilities For RF System Validation Engineer Resume
- Validation experience within medical device or drug delivery pharmaceutical manufacturing
- Knowledge of cGMP Cleaning Validation requirements and techniques, GMP Process and Product Validation requirements and techniques
- Experience validating CTUs, Steriline Tunnels, Clean Steam Autoclaves
- Computer knowledge / Word Processing skills
- Validation experience, preferably in the pharmaceutical industry sterilizing equipment
8
Responsibilities For Battery Validation Engineer Resume
- Experience in a Quality Engineering or Validation role within the Medical Device and/or Biopharmaceutical industries
- Validation experience within pharmaceutical manufacturing
- Process and cleaning validation experience
- Advanced Programming skills (i.e LabVIEW-CLAD, TestStand, TCL, Python, JAVA, C)
- Good understanding of Pharmaceutical processes and plant design, cGMP principles, documentation practices and validation requirements
- Prioritize projects to meet validation schedule with engineering and operations
- Experienced conducting equipment and process validation work in medical device or Pharmaceutical industries
- Skilled in the setup and calibration of a Kaye Validator for temperature mapping studies
- Relevant experience in pharmaceutical validation testing discipline
9
Responsibilities For RF Systems Validation Engineer TX Resume
- Strong process understanding of moist heat, porous load sterilization and proficiency in use of the Kaye Validator
- Assists with development of validation protocols. Generates validation protocols using templates
- Validation planning and validation of End-To-End connectivity
- Expert Excel skills including PivotTables and data analysis
- Experience in an Equipment and/or Process Validation Engineering role within a pharmaceutical or medical device company
- Experiences in metrology and validation of pharmaceutical manufacturing equipment
10
Responsibilities For Connected Eco System Validation Engineer Resume
- Develops validation protocols and reports, ensuring alignment with Validation policies and guidance documents
- Good knowledge & working experience in C,C, Python
- Experience with running field trials of cellular/GNSS/wireless devices-Experience in script development
- Good knowledge & working experience in C , C++, C
- Experience in establishing site and program validation strategies that are aligned with current industry mindsets
- Project management, communication, and technical writing skills are required
- Experience with environmental product validation or testing
- Validation experience in a cGMP environment; preferably in a pharmaceutical or Medical Device manufacturing environment
- Automotive test and validation engineering experience
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