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

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

SRG

Latest Jobs

Manufacturing Engineer