Senior Equipment Engineer
Skills
- GxP validation experience
- Calibration and metrology expertise
- Experience with CMMS or calibration systems
- Technical writing for protocols and reports
- Project management and budget tracking
- Vendor management
- Analytical and problem-solving skills
- Strong interpersonal and communication skills
Responsibilities
- Lead onboarding and qualification of new GMP equipment (URS → FAT/SAT → installation → release)
- Manage asset lifecycle, induction, validation, calibration oversight, and CMMS coordination
- Draft and manage URS, system impact assessments, IQ/OQ protocols, execution, and summary reports
- Coordinate installation, engineering start-up, and validation activities with cross-functional teams
- Manage projects including scope, budgets, risk assessments, PO requisitions, and vendor contracts
- Oversee third-party maintenance and calibration vendors
- Assist or manage implementation and oversight of computerized environmental monitoring systems
- Represent Engineering in project team meetings and support manufacturing, QA, QC, and supply chain
Education
- Bachelor’s degree in an engineering discipline (required) or equivalent
- Graduate degree in Engineering preferred or equivalent experience considered
Benefits
- Competitive benefits package
- Challenging career growth opportunities in a CDMO
- Supportive, performance-recognizing work environment
- Paid time off and holidays
- Health, dental, and vision coverage
- 401(k) or retirement plan (typical for company stage)
Average salary estimate
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