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Validation Engineer

Emeryville, CA 94608

Posted: 08/26/2022 Employment Type: Contract Job Category: Engineering Job Number: 485932 Country: United States Is job remote?: No

Job Description

Duties:
 

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.
Skills:
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.
     

Occupational Demands:
  • Be able to lift 20 lbs.
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.
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