4560 Horton Street, Building R Emeryville, CA 94608 US
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.
- The incumbent prepares validation plans, protocols, test scripts and reports throughout all stages of validation lifecycle.
- Furthermore, the incumbent will be 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.
- 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.
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.
• Ability to work independently in a matrix team environment, influence team decisions, exercise sound judgement in determining compliant & robust validation approach.
• Ability to multi-task with demonstrated track records in meeting deliverable timelines.
• Must demonstrate the ability to think critically & analytically with acumen for trouble-shooting & problem solving.
• Good interpersonal skills, accountable with excellent verbal & written communication skills.
• Ability to function effectively & independently in a fast-paced & dynamic environment.
• Self-motivated & willing to tackle assignments & development opportunities outside of job scope.
• Ability to interpret engineering & facility drawings such as facility layouts, blueprints, material/process flow diagrams & equipment P&IDs.
• Understanding of basic statistics, acceptance sampling & familiar with statistics software such as Minitab & JMP
• Strong team player aligned with Corporate Values.
• 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.
• Hands-on engineer.
• The engineer is expected to be proficient in at least 4 of 7 validation core expertise.
Validation Core Expertise:
- Facility Qualification
• Equipment Qualification
• Utilities Qualification
• Cleaning Validation
• Process Validation
• Sterilization Validation
• Computerized System Validation
- Expert Microsoft Word / PowerPoint & Intermediate Microsoft Excel skills are required.
- Be able to lift 20 lbs.
- Minimum Bachelor' s Degree in Engineering or Science discipline, advanced degree is a plus.
- Minimum 7+ years of relevant validation experience in regulated industry.