About The Position
We are seeking an experienced Commissioning & Qualification (C&Q) Engineer to support qualification activities for analytical and microbiology laboratory equipment within a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. The consultant will be responsible for protocol development and execution of equipment qualification activities, ensuring compliance with cGMP regulations, FDA expectations, and industry best practices.
Requirements
- Bachelor’s Degree in Engineering, Chemistry, Microbiology, or a related scientific discipline.
Nice To Haves
- 3+ years of experience in commissioning, qualification, or validation within pharmaceutical, biotechnology, or medical device industries.
- Strong understanding of cGMP, FDA regulations, and validation lifecycle.
- 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.
- Experience with equipment lifecycle management.
- Hands-on qualification experience with one or more of the following laboratory systems is preferred: Analytical Laboratory Equipment (HPLC / UPLC, Gas Chromatography (GC), Dissolution Systems, TOC Analyzers, UV-Vis Spectrophotometers, Analytical Balances), Microbiology Laboratory Equipment (Incubators, Autoclaves, Biological Safety Cabinets, Stability Chambers, Environmental Chambers, Refrigerators and Freezers, Particle Counters).
Responsibilities
- Lead and support Commissioning & Qualification activities for laboratory equipment and utilities.
- Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Perform impact assessments and risk assessments related to equipment qualification.
- Support equipment startup and commissioning activities.
- Ensure compliance with cGMP regulations, FDA guidelines, and internal quality procedures.
- Author and review validation documentation, including protocols, reports, and discrepancy investigations.
- Collaborate with Quality Assurance, Engineering, Validation, and Laboratory teams.
- Support change control, deviation investigations, and CAPA implementation when required.
- Ensure adherence to data integrity principles (ALCOA / ALCOA+).
Benefits
- medical
- dental
- vision care
- backup dependent care
- adoption assistance
- infertility coverage
- family building support
- behavioral health solutions
- paid parental leave
- paid caregiver leave
- training programs
- professional development resources
- mentorship programs
- employee resource groups
- volunteer activities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
