CQV/Validation Engineer

About CAI

Established in 1996, CAI is a fully employee-owned enterprise with nearly 700 professionals globally. It specializes in commissioning, qualification, validation, startup, project management, and consulting services focused on operational preparedness for FDA-regulated and other critical industries.

The company emphasizes client-first service, integrity, teamwork, societal contribution, and forward-thinking. CAI fosters a culture where individual achievement translates into team success, promoting respect, a positive attitude, and collaboration. Employees gain exposure to state-of-the-art technologies in advanced medicine and receive professional training and certifications, enhancing their role in delivering life-saving treatments.

Key Responsibilities

• Lead and execute Commissioning, Qualification, and Validation activities prioritizing safety.
• Manage the entire lifecycle of C&Q documentation from SLIA creation to OQ completion.
• Develop C&Q procedures for assigned projects and approve TOPs (Test Operation Procedures).
• Support planning for commissioning spares and consumables.
• Ensure timely completion of C&Q tasks according to project schedules and monitor their progress.
• Prepare Qualification Summary Reports (QSR) and maintain the Requirement Traceability Matrix (RTM).
• Participate in design reviews, shakedown, commissioning, FATs, IQ, OQ, and PQ activities.
• Oversee various components of C&Q such as change controls, contractor and vendor management, document control, and punch list handling.
• Collaborate with project contractors and equipment vendors to carry out necessary tests.
• Allocate project resources to optimize project execution efficiency.
• Coordinate support during the execution phase of C&Q activities.

Qualifications and Requirements

• Possess a BS or MS degree in science, engineering, or an equivalent field.
• Have at least 3 years of subject matter expertise in CQV within life sciences; experience with Clean Utilities and Filling processes is advantageous.
• Demonstrate excellent verbal and written communication abilities.
• Possess strong analytical and problem-solving skills.
• Be customer-service oriented.
• Show proficiency in life science manufacturing workflows, such as biotech, aseptic fill/finish, oral solid dosage (OSD), gene therapy, or similar sectors.
• Willingness to travel within the country and abroad as required.

Diversity and Equal Opportunity

CAI is committed to equitable employment practices, values veteran representation, and promotes a diverse workplace. The company pledges fairness for all employees, clients, and society. The job description is comprehensive but not exhaustive; candidates may need to perform additional responsibilities as assigned.

Use of AI in Hiring

CAI may incorporate AI technologies to assist recruitment phases like application review and resume analysis. However, final hiring decisions remain under human authority. For inquiries regarding data usage during hiring, candidates can contact CAI directly.