What are the responsibilities and job description for the Process Validation Engineer position at ELIQUENT Life Sciences?
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. For more information, please visit our website at eliquent.com.
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