Senior Manufacturing Validation Engineer (Sterilization/Microbiology) - On‑Site | Mansfield, MA
Contract: 12+ months
Pay: Up to $62/hr (W2)

We're ramping up risk mitigation and CAPA remediation efforts and looking for a seasoned Validation Engineer to lead critical sterilization/microbiology validation work for medical devices. This is a hands‑on, cross‑functional role partnering with Product Design, Facilities, Lab, and Microbiology teams.

What you'll do

• Drive design transfer for processes tied to endotoxin requirements
• Create and execute Validation Master Plans, protocols (IQ/OQ/PQ), and completion reports
• Lead sterility-focused validation activities; author and drive protocols and reports
• Develop statistically based sampling plans; provide statistical analysis to support reports
• Own change controls/ECOs; troubleshoot equipment/processes during validation runs
• Investigate and close non‑conformances and CAPAs; prepare investigation reports
• Support regulatory compliance (FDA, ISO, OSHA, EPA) and external audits (e.g., BSI)
• Collaborate across Manufacturing, Engineering, Regulatory, and QA on project teams

What you'll bring

• BS in Engineering (Mechanical, Industrial, Electrical, Chemical, Biomedical) or related science
• 7+ years in medical device (pharma experience also valued)
• Proven sterility/sterilization validation expertise and endotoxin knowledge
• Strong project management skills; ability to lead cross‑functional teams
• Familiarity with GMP/ISO requirements; excellent written/verbal communication
• Lean/Six Sigma (Green/Black Belt) a plus; PE license nice to have

Why this role

• On‑site at a major medical device facility in Mansfield, MA
• Direct relationship with the hiring manager