Process Validation Engineer
Listed on 2026-09-05
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Engineering
Validation Engineer, Quality Engineering, Pharma Engineer
Process Validation Engineer
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients' needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices.
We are seeking a Process Validation Engineer to support pharmaceutical manufacturing projects, including a new fill line implementation and revalidation activities.
Key Responsibilities:
- Develop and execute process validation strategies for new fill line projects
- Support Process Performance Qualification (PPQ) studies and validation activities
- Coordinate and evaluate aseptic media fill runs
- Perform revalidation activities for pre-filled syringe (PFS) fill lines
- Support tech transfer projects across new and existing manufacturing lines
- Conduct risk assessments and ensure cGMP compliance
- Support CQV, qualification, and validation documentation activities
- Conduct and support smoke studies for aseptic processing environments
- Support qualification of automated visual inspection systems
Required Skills:
- Process Validation
- Validation Protocol Development & Execution
- Smoke Studies
- Pharmaceutical Manufacturing Experience
- cGMP Knowledge
- Strong Documentation & Communication Skills
Preferred
Skills:
- PPQ Experience
- Pre-Filled Syringe (PFS) Fill Line Experience
- Media Fill Support
- CQV / Qualification Experience
- Tech Transfer Experience
- Automated Visual Inspection Qualification
Benefits:
What We Offer:
Competitive Compensation:
Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
Career Development:
Opportunities for professional growth and advancement within a supportive and innovative environment.
Work-Life Balance:
Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
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