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.