CQV/Validation Engineer

About CAI

CAI is a fully employee-owned enterprise founded in 1996, expanding to nearly 700 employees worldwide. The company specializes in commissioning, qualification, validation, startup, project management, and consulting for industries regulated by the FDA and other critical sectors.

Our principle is straightforward: prioritize client interests, persist until perfection is attained, and dedicate all necessary effort.

As employee owners, we uphold core values that guide our professional and personal conduct:

• Act with integrity
• Support and serve colleagues
• Contribute to society
• Plan and work for the future

We emphasize collective success, teamwork, respect, and a proactive attitude, which have driven our significant growth.

Team members engage with cutting-edge technologies in advanced medicine, collaborating with acknowledged experts to deliver life-saving treatments. We invest in career growth through practical certifications and ongoing professional training, fostering a collaborative environment that benefits our clients with outstanding service.

Role Overview and Responsibilities

• Lead and perform commissioning, qualification, and validation activities with a strong focus on safety.
• Manage the documentation lifecycle from Site-Level Installation Activities (SLIA) through Operational Qualification (OQ) completion.
• Develop commissioning and qualification procedures for assigned projects.
• Approve Test Operation Procedures (TOPs).
• Assist in planning and scoping for commissioning spares and consumables.
• Deliver commissioning and qualification tasks to align with project timelines.
• Monitor progress of C&Q activities diligently.
• Prepare Qualification Summary Reports and supervise Requirement Traceability Matrices.
• Carry out design reviews, equipment shakedown, Factory Acceptance Tests (FATs), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) tasks.
• Oversee change controls, contractor/vendor management, document control, and punch list tracking within C&Q processes.
• Collaborate with project contractors and equipment suppliers to execute necessary tests.
• Allocate project resources effectively to meet deliverables.
• Provide coordinated support throughout C&Q execution stages.

Candidate Profile and Requirements

• Bachelor's or Master's degree in science, engineering, or equivalent field.
• At least three years’ experience as a CQV Subject Matter Expert in life sciences; background in clean utilities and filling processes is advantageous.
• Strong verbal and written communication capabilities.
• Excellent analytical and problem-solving aptitude.
• Customer-oriented approach with service excellence.
• Familiarity with biotech manufacturing processes, including aseptic fill/finish, oral solid dosage forms, gene therapy, or comparable fields.
• Willingness to travel domestically and internationally as necessary.

Additional Information

We are an equal opportunity employer valuing veterans and diversity in the workplace as strengths. We operate fairly and equitably for employees, customers, and society at large. This role may involve additional responsibilities beyond those stated.

Our recruitment process may involve artificial intelligence tools to assist in reviewing applications and verifying information, but final decisions rest with human recruiters. Candidates interested in data processing details can contact us for further information.