What are the responsibilities and job description for the Senior Manufacturing Validation Engineer (Sterilization/Microbiology) :: Mansfield, Massachusetts (Onsite) position at Jobs via Dice?
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Stellent IT LLC, is seeking the following. Apply via Dice today!
Job Title Senior Manufacturing Validation Engineer (Sterilization/Microbiology)
Location Mansfield, Massachusetts (Onsite)
Duration 12 months
Job Description:-
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
Email -
LinkedIn -
STELLENT IT A Nationally Recognized Minority Certified Enterprise
"Happiness can be found, even in the darkest of times, if one only remembers to turn on the light."
Job Title Senior Manufacturing Validation Engineer (Sterilization/Microbiology)
Location Mansfield, Massachusetts (Onsite)
Duration 12 months
Job Description:-
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
- 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
Email -
LinkedIn -
STELLENT IT A Nationally Recognized Minority Certified Enterprise
"Happiness can be found, even in the darkest of times, if one only remembers to turn on the light."
- JK Rowling