Senior Commissioning & Qualification (C&Q) Engineer

At-a-Glance: Join a leading technology solutions and compliance consulting company as a Senior Commissioning & Qualification (C&Q) Engineer to advance your career. Position Type: ContractHybrid (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. #HbM6349