At-a-Glance: Join a leading technology solutions and compliance consulting company as a Senior Commissioning & Qualification (C&Q) Engineerto advance your career.
Position Type:- Contract
- Hybrid (2-3 days a week onsite)
Required:- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering, Pharmaceutical Engineering, Biotechnology, Microbiology, or a related field.
- Minimum 7 years of experience in commissioning, qualification, validation, or equipment engineering in GMP-regulated environments.
- At least 3 years of experience leading complex C&Q protocol development and execution.
- Experience qualifying aseptic-processing equipment, pharmaceutical isolators, restricted access barrier systems, Rapid Transfer Ports, or related systems.
- Hands-on experience with VHP cycle development, material transfer chamber qualification, steam autoclave PQ, or thermal mapping studies.
- Strong understanding of GMP, GDP, data integrity, risk-based qualification, and qualification lifecycle requirements.
- Experience with technical systems such as Ellab data loggers, thermal validation software, PLC/HMI controls, and electronic qualification platforms.
Responsibilities:- Review project requirements and documentation to define qualification scope and strategy.
- Develop, review, and execute commissioning and qualification protocols for various systems.
- Lead VHP cycle development and qualification for isolators and material transfer chambers.
- Develop and execute autoclave performance qualification studies.
- Perform functional testing of equipment and controls under various conditions.
- Investigate qualification discrepancies and coordinate corrective actions.
- Prepare qualification reports and coordinate with cross-functional teams for project closeout.
If your background aligns with what we’re looking for, you may receive a call from Ava, our virtual recruiter, for a brief screening conversation. Ava will ask a few questions about your experience and interest in the opportunity.
#LI-VK1
#HbM6349
