Summary: Seeking a skilled Computer System Validation (CSV) Specialist to support commissioning and qualification efforts for a cell therapy manufacturing project.

Bachelor's degree in Engineering, Computer Science, or Life Sciences

5+ years experience in CSV within GMP-regulated environments

Strong knowledge of FDA regulations and cGMP standards

Experience with DeltaV control systems and document management systems

Preferred Skills:

Experience in pharmaceuticals or biotechnology industries

Responsibilities:

Develop and execute CSV protocols (IQ, OQ, PQ) for manufacturing equipment

Collaborate with automation and validation teams to ensure compliance

Manage document lifecycle in compliance with project systems

Participate in weekly project meetings for alignment on needs and issue resolution

Conduct risk assessments and manage deviations for compliance reports

Oversee vendor interactions and track deliverables

Pay Details: $31.00 to $42.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance