Senior Manufacturing Validation Engineer (Sterilization/Microbiology) :: Mansfield, Massachusetts (Onsite)

Overview

On Site
Full Time
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - long term

Skills

Manufacturing
Risk Management
Corrective And Preventive Action
Product Design
Microbiology
IQ
OQ
PQ
Statistics
Regulatory Compliance
Auditing
Business Systems Interface
Collaboration
Manufacturing Engineering
Quality Assurance
Mechanical Engineering
Electrical Engineering
Biomedicine
Science
Medical Devices
Pharmaceutics
Project Management
GMP
ISO 9000
Communication
Lean Six Sigma
LinkedIn
Oracle UCM

Job Details

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

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

Akshit Sisonia - Sr. Technical Recruiter

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LinkedIn -

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