Senior CQV Engineer

Senior CQV Engineer at Katalyst CRO

We’re seeking a Senior CQV Engineer to play a critical role in the startup and qualification of a new early‑phase clinical biomanufacturing facility, encompassing clean rooms, utilities, and a wide range of systems and equipment.

• Plan, execute, and document commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client‑specific requirements.
• Author, edit, and execute technical commissioning, qualification, and validation documentation for facilities, utilities, and standard equipment/systems/software.
• Consult clients on regulatory validation processes and industry‑accepted practices.
• Collaborate with cross‑functional teams—including Manufacturing, Facilities, Quality Control, and Quality Assurance—to scope and execute validation activities.
• Take independent leadership on project(s).
• Manage and work collaboratively with clients' quality representatives to complete deviation investigation and resolution for problems and issues encountered during execution activities, including root cause analysis.

• Bachelor's degree in engineering, life sciences, or a related field.
• 5+ years of experience in validation within a regulated industry (e.g., pharma, biotech).
• Experience with facility, utility, equipment, and computer system validation, preferably in startup of early‑phase clinical biomanufacturing facilities.
• Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry guidelines (ISPE, GAMP).
• Experience working with startup clients lacking well‑established procedures and standards.
• Excellent documentation, analytical, and problem‑solving skills.
• Ability to work independently and as part of a team.

• Mid‑Senior level

• Contract

• Pharmaceutical Manufacturing

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