6304 - Cleaning Validation Engineer / Sr. Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• →Lead cleaning validation strategy and execution for tech transfer programs
• →Perform soil evaluation and ranking to identify worst-case products and residues
• →Define worst-case equipment trains/circuits and justification approach
• →Develop and support PQ strategy for cleaning validation
• →Leverage existing validation data (including prior site data) to support a risk-based approach
• →Author and review validation protocols, reports, and risk assessments
• →Support cleanability and sample recovery considerations as needed
• →Coordinate and help plan/schedule validation activities across multiple workstreams
• →Manage deviations, investigations, and CAPAs related to cleaning validation
• →Collaborate cross-functionally with Manufacturing, Quality, MS&T, and Engineering
• →Ensure compliance with cGMP and regulatory expectations

• Bachelor’s degree in Engineering, Chemistry, or related field
• 5+ years of cleaning validation experience in GMP environment
• Strong experience with:
  • Soil evaluation and worst-case determination
  • Cleaning validation PQ strategy development
  • Risk-based validation approaches leveraging existing data
  • MACO calculations and acceptance limits
• Experience supporting tech transfer or NPI programs
• Ability to manage multiple priorities and workstreams independently

This role requires the ability to be on-site, full-time in Devens, MA.