Commissioning and Qualification (C&Q) Engineer – Laboratory Equipment
Recruiting.com
full-time
Posted on:
Location Type: Office
Location: Manatí • Puerto Rico
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About the role
- Support qualification activities for laboratory equipment
- Lead Commissioning & Qualification activities
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
- Perform impact assessments and risk assessments
- Ensure compliance with cGMP regulations and FDA guidelines
- Author and review validation documentation
- Collaborate with Quality Assurance, Engineering, Validation, and Laboratory teams
Requirements
- Bachelor’s Degree in Engineering, Chemistry, Microbiology, or a related scientific discipline
- 3+ years of experience in commissioning, qualification, or validation within pharmaceutical, biotechnology, or medical device industries
- Strong understanding of cGMP and FDA regulations
- Experience generating and executing IQ, OQ, and PQ documentation
- Strong technical writing and documentation skills
- Experience working under FDA, EMA, or other regulatory inspections
- Familiarity with ASTM E2500 risk-based validation approaches
- Knowledge of 21 CFR Part 11 and data integrity requirements
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Educational assistance
- 401(k) retirement plan
- Flexible work arrangements
- Professional development resources
- Employee resource groups
- Volunteer activities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)risk assessmentsimpact assessmentstechnical writingvalidation documentationcGMP regulationsFDA guidelinesASTM E2500
Soft Skills
collaborationleadership