CQV/Validation Engineer

About CAI

Founded in 1996, CAI is a fully employee-owned company with nearly 700 staff globally. We specialize in providing commissioning, qualification, validation, startup, project management, and consulting services for FDA-regulated and other critical industries that require operational readiness. Our ethos emphasizes putting client needs first, unwavering commitment to quality, and a can-do attitude. As owners, we uphold foundational principles such as integrity, mutual support, societal service, and future-oriented work. Our collaborative environment fosters teamwork, respect, and professional growth, exposing our staff to pioneering technologies in advanced medicine.

Job Responsibilities

• Lead and execute Commissioning, Qualification, and Validation team tasks with a focus on safety adherence.
• Oversee the entire lifecycle of C&Q documentation and execution from SLIA generation to Operational Qualification completion.
• Develop Commissioning and Qualification procedures tailored to project needs.
• Approve Test Operation Procedures (TOPs).
• Coordinate the planning and procurement of commissioning spares and consumables.
• Ensure timely delivery of C&Q activities according to project schedules.
• Monitor and report on the progress of C&Q activities.
• Prepare Qualification Summary Reports and manage the Requirement Traceability Matrix.
• Conduct design reviews, shakedown processes, commissioning, Factory Acceptance Testing, Installation Qualification, Operational Qualification, and Performance Qualification activities.
• Manage various aspects of C&Q including change controls, contractor and vendor oversight, document management, and punch list tracking.
• Collaborate with project contractors and equipment vendors to complete required testing.
• Assign project resources for optimal achievement of deliverables.
• Provide coordination and support during C&Q execution phases.

Requirements

• Bachelor’s or Master’s degree in a science or engineering discipline, or equivalent qualification.
• Minimum of three years’ experience as a Subject Matter Expert in CQV within life sciences, with preference for clean utilities and filling processes.
• Strong verbal and written communication abilities.
• Effective problem-solving skills.
• Customer-service oriented mindset.
• Familiarity with life science manufacturing processes such as biotechnology, aseptic fill/finish, oral solid dose, gene therapy, or related fields.
• Willingness to travel both domestically and internationally when needed.

Additional Information

CAI is committed to equal opportunity employment and values diversity, including veterans, within its workforce. We ensure equitable treatment for employees, clients, and society at large. This role description may evolve to include other related duties.

Note: Artificial intelligence tools might be utilized during parts of the hiring process for application and resume analysis to support recruitment efforts. Human judgment remains paramount in final hiring decisions. Inquiries about data processing are welcome.