Process Validation Engineer

Seeking a Process Validation Engineer to support multiple pharmaceutical manufacturing projects focused on process validation, tech transfer, and revalidation activities for fill-finish operations. The role involves validation strategy development, PPQ execution, aseptic process support, and cross‑functional collaboration to ensure regulatory compliance and operational excellence.

• 3+ years of Process Validation experience within pharmaceutical or biopharmaceutical manufacturing
• Experience with Process Performance Qualification (PPQ) studies
• Hands‑on experience supporting pre-filled syringe (PFS) fill lines
• Knowledge of aseptic processing, media fills, and smoke studies
• Experience with validation protocols, reports, and risk assessments
• Strong understanding of cGMP, FDA, and regulatory requirements
• Experience supporting tech transfer activities
• Excellent communication and stakeholder management skills

• Develop and execute process validation strategies for fill‑finish manufacturing processes.
• Lead and support PPQ studies to demonstrate process consistency and compliance.
• Perform revalidation activities for PFS filling operations.
• Coordinate and evaluate aseptic media fill runs.
• Support technology transfer projects for new and existing production lines.
• Prepare and review validation documentation, protocols, reports, and risk assessments.
• Conduct and support smoke studies to verify aseptic process integrity.
• Collaborate with manufacturing, quality, engineering, and validation teams to ensure successful project execution.