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.
