Senior Validation Engineer
$152,000–$197,000 year
On-siteFramingham, Massachusetts, United States
Job Summary
Lead validation technical efforts to ensure biotech facility equipment, utilities, instrumentation, and computerized systems remain qualified and maintained in a validated state per regulatory guidance. Coordinate scheduling, execution, and review of qualification protocols with internal customers and external contractors while project managing validation campaigns for change control and requalification assessments. Establish and maintain validation project plans, procedures, and lifecycle documents in accordance with cGMP, GDP, and ALCOA principles. Author investigations for deviations and CAPAs, support troubleshooting of equipment failures, and deliver training on validation program elements. Ensure all work adheres to Standard Operating Procedures and assist with audits, non-conformance investigations, and change control activities. Maintain strong understanding of current regulatory landscape and evolving industry guidance.
Required Qualifications
- Bachelor's degree in Scientific, Engineering or similar subject
- MSc or MS
- A minimum of seven years professional experience in validation, engineering, or operations
- A minimum of seven years relevant experience in a cGMP environment
- Experience with GMP utilities and equipment
- Good knowledge of cGMP, GDP, and applicable regulatory requirements
- This position is based in our Framingham location
- typically has a 5-day on-site expectation
Desired Qualifications
- MSc or MS preferred
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