Contract position: Our client in San Diego is looking for an Validation Engineer to start right away who will support validation activities related to facility, manufacturing process, cleaning process, equipment, critical utilities, and computerized systems.Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Part of the team responsible for new facility/equipment/process, process and equipment changes, and periodic requalification/revalidation
- Responsible for coordination and execution of validation activities and be expected to play a key role in developing and driving risk based validation approach during essential stages of product lifecycle including process design/control strategy development, technology transfer, equipment/utilities commissioning & qualification (C&Q), process performance qualification (PPQ), continued process verification (CPV), process control/risk management, and product decommissioning.
- Perform qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification), cleaning validation, and process validation.
- Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis.
- BS Degree Required
- Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, and Process Validation.
- Familiarity and demonstrated knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes.
- Ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs
- 5+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 2 of 7 validation core expertise.
- Understanding of basic statistics, acceptance sampling, and familiar with statistics software such as Minitab and JMP
- Familiar with applicable domestic and international GMP regulations impacting validation requirements, 21 CFR 210. Familiar with current industry guidance documents impacting validation best practices, FDA Process Validation guidance, ISO 13485, ISO 14971, ASTM E2500, and applicable PDA Technical Reports Experience with customer and regulatory inspection.
- Contractor Benefits Available
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.