Validation Engineer
$97,308–$121,608 year
On-siteBuena, New Jersey, United States
Job Summary
Commission equipment, process, facilities, and utilities for qualification while acting as a subject matter expert for all site validation activities. Coordinate validation efforts with stakeholders and commissioning agents to bring systems online, utilizing project management skills to plan cross-functional team efforts. Author, review, and support technical documents including change controls, CAPAs, and engineering documentation while identifying and resolving non-conformances during IQ/OQ/PQ execution. Generate regulatory-compliant reports and summarize results for regulatory agencies, mentoring less experienced team members as needed.
Required Qualifications
- Bachelor's degree in a STEM field required; i.e. engineering, chemistry, or relevant industry experience.
- 4+ years of validation experience, preferably in a highly regulated environment.
- Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.)
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
- Ability to maintain a gowning qualification and adhere to aseptic practices.
Desired Qualifications
- Experience in project management preferred
- Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
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