Validation Lead Jobs
Validation Lead jobs are open across pharmaceuticals, medical devices, manufacturing, and biotech, from associate to senior and principal levels, with specializations in process validation, equipment qualification, and CSV. See the openings below and apply to the ones that match your experience.
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Showing 5 of 58+ Validation Lead jobs
Lead Process Validation Specialist - Medical Devices & Assembly Processes
Location: Baltimore, Maryland
Work Arrangement: Onsite
Engagement Type: Contract / Consulting
Function: Validation / Engineering / Design Transfer
Duration: 3 to 6 months
Position Overview
VTI Life Sciences is seeking a Lead Process Validation Specialist to provide onsite, hands-on technical leadership for medical device manufacturing and assembly process validation. The consultant will support the transfer, scale-up, and validation of fiber manufacturing and related processes, establishing scientifically justified strategies and leading execution from process characterization through qualification, validation, and continued process monitoring.
This role requires an expert in Validation Master Plans, risk assessments, IQ/OQ/PQ, and applied statistical analysis, with strong project management skills to lead several technical validation efforts simultaneously. The successful candidate will take a firm, evidence-based stance on lean validation, ensuring that activities are proportionate to risk and that conclusions are supported by defensible data.
Candidates who reside in the Baltimore, Maryland area or are willing to relocate are preferred. 90% Onsite availability is required.
Key Responsibilities
- Develop and maintain Validation Master Plans and process-specific validation strategies for medical device manufacturing and assembly operations.
- Lead process risk assessments, including process FMEAs as appropriate, and translate findings into validation scope, challenge conditions, controls, and acceptance criteria.
- Author, review, and lead execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
- Apply statistical techniques such as design of experiments, measurement system analysis, process capability analysis, hypothesis testing, and confidence/reliability-based sampling, as appropriate.
- Provide direct technical oversight during validation runs, troubleshoot unexpected results, and support deviation investigations and scientifically justified corrective actions.
- Coordinate supporting qualification and validation activities, including test and inspection methods, equipment, cleaning, packaging, sterilization, and environmental or process controls, as applicable.
- Manage multiple validation assignments, including technical deliverables, execution readiness, resource needs, dependencies, and timely closure, in partnership with the Technical Project Manager.
- Champion lean validation by challenging unnecessary testing, avoiding redundant documentation, and documenting sound risk-based rationales.
- Coach engineers and scientists on process development, characterization, qualification, verification, and formal validation.
Required Qualifications
- Bachelor’s degree in Engineering, Science, Biomedical Engineering, Chemical Engineering, or a related technical discipline.
- Approximately 12+ years of relevant technical experience, including substantial hands-on medical device process validation experience.
- Demonstrated expertise in medical device manufacturing and assembly process validation.
- Expert-level capability in Validation Master Plans, risk assessments, and IQ/OQ/PQ development, execution, and reporting.
- Strong statistical analysis skills and experience translating process data into defensible validation decisions.
- Proficiency with Minitab, JMP, or comparable statistical analysis software.
- Experience establishing process parameters, challenge conditions, acceptance criteria, and sampling rationales.
- Experience supporting design transfer, process scale-up, and transition from development into manufacturing.
- Strong working knowledge of change control, deviations, investigations, and validation documentation within an ISO 13485 quality system and FDA-regulated medical device environment.
- Strong project management and organizational skills, with demonstrated ability to lead several ongoing validation efforts.
- Demonstrated commitment to lean, scientifically sound, risk-based validation.
- Ability to exercise independent technical judgment, constructively challenge inadequate approaches, and mentor less-experienced personnel.
- Ability to work onsite in Baltimore, Maryland.
Preferred Qualifications
- Electrospinning process experience is a significant advantage.
- Experience with fiber manufacturing, biomaterials, polymers, or implantable medical devices.
- Experience with packaging, sterilization, cleaning, and test method validation.
- Experience developing continued process monitoring strategies and manufacturing control plans.
- ASQ CQE, CRE, Lean Six Sigma, or comparable certification.
- Current residence in the Baltimore area or willingness to relocate.
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Lead Process Validation Specialist - Medical Devices & Assembly Processes
Location: Baltimore, Maryland
Work Arrangement: Onsite
Engagement Type: Contract / Consulting
Function: Validation / Engineering / Design Transfer
Duration: 3 to 6 months
Position Overview
VTI Life Sciences is seeking a Lead Process Validation Specialist to provide onsite, hands-on technical leadership for medical device manufacturing and assembly process validation. The consultant will support the transfer, scale-up, and validation of fiber manufacturing and related processes, establishing scientifically justified strategies and leading execution from process characterization through qualification, validation, and continued process monitoring.
This role requires an expert in Validation Master Plans, risk assessments, IQ/OQ/PQ, and applied statistical analysis, with strong project management skills to lead several technical validation efforts simultaneously. The successful candidate will take a firm, evidence-based stance on lean validation, ensuring that activities are proportionate to risk and that conclusions are supported by defensible data.
Candidates who reside in the Baltimore, Maryland area or are willing to relocate are preferred. 90% Onsite availability is required.
Key Responsibilities
- Develop and maintain Validation Master Plans and process-specific validation strategies for medical device manufacturing and assembly operations.
- Lead process risk assessments, including process FMEAs as appropriate, and translate findings into validation scope, challenge conditions, controls, and acceptance criteria.
- Author, review, and lead execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
- Apply statistical techniques such as design of experiments, measurement system analysis, process capability analysis, hypothesis testing, and confidence/reliability-based sampling, as appropriate.
- Provide direct technical oversight during validation runs, troubleshoot unexpected results, and support deviation investigations and scientifically justified corrective actions.
- Coordinate supporting qualification and validation activities, including test and inspection methods, equipment, cleaning, packaging, sterilization, and environmental or process controls, as applicable.
- Manage multiple validation assignments, including technical deliverables, execution readiness, resource needs, dependencies, and timely closure, in partnership with the Technical Project Manager.
- Champion lean validation by challenging unnecessary testing, avoiding redundant documentation, and documenting sound risk-based rationales.
- Coach engineers and scientists on process development, characterization, qualification, verification, and formal validation.
Required Qualifications
- Bachelor’s degree in Engineering, Science, Biomedical Engineering, Chemical Engineering, or a related technical discipline.
- Approximately 12+ years of relevant technical experience, including substantial hands-on medical device process validation experience.
- Demonstrated expertise in medical device manufacturing and assembly process validation.
- Expert-level capability in Validation Master Plans, risk assessments, and IQ/OQ/PQ development, execution, and reporting.
- Strong statistical analysis skills and experience translating process data into defensible validation decisions.
- Proficiency with Minitab, JMP, or comparable statistical analysis software.
- Experience establishing process parameters, challenge conditions, acceptance criteria, and sampling rationales.
- Experience supporting design transfer, process scale-up, and transition from development into manufacturing.
- Strong working knowledge of change control, deviations, investigations, and validation documentation within an ISO 13485 quality system and FDA-regulated medical device environment.
- Strong project management and organizational skills, with demonstrated ability to lead several ongoing validation efforts.
- Demonstrated commitment to lean, scientifically sound, risk-based validation.
- Ability to exercise independent technical judgment, constructively challenge inadequate approaches, and mentor less-experienced personnel.
- Ability to work onsite in Baltimore, Maryland.
Preferred Qualifications
- Electrospinning process experience is a significant advantage.
- Experience with fiber manufacturing, biomaterials, polymers, or implantable medical devices.
- Experience with packaging, sterilization, cleaning, and test method validation.
- Experience developing continued process monitoring strategies and manufacturing control plans.
- ASQ CQE, CRE, Lean Six Sigma, or comparable certification.
- Current residence in the Baltimore area or willingness to relocate.
ILkYSSAWz2
Validation Lead Jobs by Experience Level
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Find Validation Lead JobsValidation Lead Job Market
Who's Hiring
Top Industries Hiring
- Technology & Software
- Consulting & Professional Services
- Automotive
- Electronics & Hardware
What Employers Look For
The qualifications that appear most often in validation lead jobs.
- Bachelor's degree in engineering, life sciences, chemistry, or a closely related field
- Experience authoring and executing IQ, OQ, and PQ protocols for equipment or processes
- Working knowledge of FDA 21 CFR Part 11 and GMP regulatory requirements
- Proficiency with computer system validation and electronic batch record platforms
- Experience leading cross-functional validation teams and managing project timelines
- Familiarity with risk assessment tools such as FMEA and HACCP in a regulated environment
Tips for Your Validation Lead Job Search
Tailor your resume to validation phases
Hiring managers scan for IQ, OQ, and PQ experience by name. List each validation phase you've led, the systems or equipment involved, and the regulatory framework that governed the work, whether FDA 21 CFR Part 11, EU Annex 11, or USP standards.
Highlight your protocol authorship directly
Many validation lead candidates bury protocol writing under a generic bullet. Pull it to the top of each role and name the document types you authored, such as validation master plans, risk assessments, and summary reports, so reviewers can assess depth immediately.
Apply early to roles that fit
Migrate Mate lists validation lead openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Filter by industry to match your compliance background
Pharmaceutical, medical device, and biotech validation roles each carry distinct regulatory expectations. If your background is CSV under Part 11, target software-heavy postings. If it's process or cleaning validation, focus on manufacturing and API production environments where those protocols dominate.
Prepare a whiteboard scenario for the interview
Validation lead interviews frequently include a live scenario where you walk through how you'd approach a failed OQ or an out-of-specification result. Practice explaining your deviation investigation process, your CAPA logic, and how you communicate hold decisions to production teams.
Negotiate scope alongside compensation
Before accepting an offer, clarify exactly which validation activities fall under your lead remit. Some roles title you a lead but seat you under a manager who controls protocol approvals. Confirm your signature authority and cross-functional access during the offer conversation, not after your first week.
Validation Lead Jobs: Frequently Asked Questions
Which companies are hiring the most validation leads?
The companies hiring the most validation leads right now include AMD, Qualcomm, and HCLTech, with the largest share of openings in California, Texas, and Maryland, based on current listings on Migrate Mate as of November 2026. Pharmaceutical manufacturers and contract development and manufacturing organizations consistently make up the largest share of postings.
How many validation lead jobs are remote?
About 59% of validation lead openings are fully remote or hybrid as of November 2026, though the role is predominantly on-site given the hands-on nature of equipment qualification and process validation. Computer system validation and documentation-heavy roles are the most likely to offer remote or hybrid arrangements, while process and cleaning validation positions almost always require facility presence.
How do you become a validation lead?
Start with a degree in engineering or a life science, then build hands-on experience executing validation protocols as a validation engineer or specialist in a regulated GMP environment. Develop fluency with FDA regulations and risk-based validation frameworks. Take ownership of full validation lifecycle projects, moving from protocol author to execution lead to approver. Building a portfolio of completed validation packages across multiple systems or processes is what typically moves candidates into a lead role.
Can you get a validation lead job without much experience?
Breaking in without experience is difficult because the role carries regulatory accountability, but it's not impossible. Candidates coming from quality assurance, manufacturing, or technical writing in a GMP setting have directly transferable skills. If your current role touches any part of the validation process, document that work precisely on your resume. Targeting associate validation lead or validation specialist postings is a realistic entry path before moving up to a full lead title.
What does the validation lead interview process look like?
Most validation lead interviews run across two to four rounds. An initial screening with a recruiter or HR contact is followed by a technical interview with a validation manager or director, where you'll be asked to walk through past protocol work and regulatory decisions. Many hiring teams include a scenario-based exercise covering deviation handling or a mock validation risk assessment. Final rounds often involve a conversation with cross-functional stakeholders such as manufacturing, quality, or IT depending on the validation domain.
Where can I find and apply to validation lead jobs?
You can find and apply to validation lead jobs on Migrate Mate, which lists current openings from across the United States. Search the listings to find roles that match your validation background, regulatory experience, and preferred industry, then apply directly to each position that fits.
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