Duration & Type: 6+ months Contract with a major pharmaceutical industry client
Location: Emeryville, California
Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.
Description: The Validation Engineer supports validation activities related to facility, manufacturing process, cleaning process, equipment, critical utilities, and computerized systems. These will encompass new facility/equipment/process, process and equipment changes, and periodic requalification/revalidation.
Responsibilities:
- Prepare validation plans, protocols, test scripts and reports throughout all stages of validation lifecycle.
- Be responsible for coordination and execution of validation activities
- 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.
- As needed coordinate and provide directions to contract personnel performing validation activities.
- Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
- Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
- Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization, and dry heat depyrogenation) development activities.
- Support periodic requalification and revalidation effort.
- Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA..
- Support gap assessment/closure, corrective actions, and compliance remediation related to Validation.
- As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections.
- As assigned mentor and manage fulltime validation engineers/specialist and contractors.
Required:
- Education: Minimum Bachelor’s Degree in Engineering or Science discipline, advanced degree is a plus.
- Minimum 7+ years of relevant validation experience in regulated industry.
- Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, and Process Validation.
- Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210).
- Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, ISO 14971, ASTM E2500, and applicable PDA Technical Reports).
- Experience with customer and regulatory inspection.
- Strong understanding of quality risk management principles, including best practice in risk based C&Q approach.
- Hands on validation experience in developing validation documentation and field execution.
- Project Management experience is a plus
- Familiarity & demonstrated knowledge of biologics manufacturing processes, including fermentation, purification & bulk filling processes.
- Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation & sterilization validation (steam sterilization & dry heat Depyrogenation) in GMP environment is required.
- Hands on experience with CIP/SIP cycle development & qualification is required.
- The engineer is expected to be proficient in at least 4 of 7 validation core expertise.
For consideration, please send resume to [email protected]
