Senior Cqv Engineer, Thousand Oaks

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 cleanrooms, utilities, and a wide range of systems and equipment.
Responsibilities
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.
Qualifications
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 *******), 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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Pharmaceutical Manufacturing
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