Validation Engineer (Contractor)

ICONMA, LLC
  • Oceanside, CA
  • $81.79–$99.99 Per Hour
  • Instant Apply
2 days ago

Job Description

Our client, a Biotech company, is looking for a Validation Engineer (Contractor) for their Oceanside, CA location.
 
Responsibilities:
  • Support the Validation Engineering team at the Client Oceanside manufacturing facility.
  • Responsible for authoring, executing, and summarizing equipment qualification and cleaning validation activities supporting both commercial stainless steel and single-use manufacturing facilities.
  • Protocol Authoring & Execution
  • Author, review, and execute qualification protocols (IQ, OQ, PQ) for systems and equipment.
  • Develop and execute Cleaning Validation (CV) and cleaning verification protocols, including sampling plans, visual inspections, and analytical test data coordination (e.g., TOC, conductivity, bioburden, and endotoxin).
  • Evaluate validation test results against defined acceptance criteria, resolve execution discrepancies via structured troubleshooting, and author protocol exceptions with cross-functional stakeholders.
  • Support continuous improvement in validation processes.
  • Document validation activities and maintain records.
  • Regulatory Compliance & GMP Standards
  • Ensure all qualification deliverables are in compliance with industry and regulatory standards, and client quality standards.
 
Requirements:
  • The ideal candidate brings hands-on experience with GMP manufacturing equipment, Clean-in-Place (CIP)/Steam-in-Place (SIP) systems, and strong verbal and written communication skills.
  • B.S. or M.S. in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline.
  • 8-10+ years of direct validation engineering experience within a cGMP biopharmaceutical or biotechnology manufacturing facility.
  • Direct hands-on experience authoring and executing both Equipment Validation (bioreactors, chromatography skids, TFF systems, autoclaves) and Cleaning Validation (CIP/SIP, residue limits, recovery studies).
  • Excellent technical writing, cross-functional collaboration, and communication skills.
  • Proven ability to independently manage timelines.
 
Why Should You Apply?Why Should You Apply?

Numbers & Facts

LocationOceanside, CA
Salary$81.79–$99.99 Per Hour

Skills

  • Analysis Skillsunmatched
  • Autoclaveunmatched
  • Biochemistryunmatched
  • Biomedical Engineeringunmatched
  • Biotech and Pharmaceuticalunmatched
  • CIP (Clean-in-Place)unmatched
  • Chemical Engineeringunmatched
  • Chromatographyunmatched
  • Cleaning Equipmentunmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Engineeringunmatched
  • Equipment Validationunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Health Planunmatched
  • Industry Standardsunmatched
  • Manufacturingunmatched
  • Manufacturing Equipmentunmatched
  • Mechanical Engineeringunmatched
  • Presentation/Verbal Skillsunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Quality Metricsunmatched
  • Record Keepingunmatched
  • Regulatory Complianceunmatched
  • SIP (Session Initiation Protocol)unmatched
  • SIP (Sterilization-in-Place)unmatched
  • Team Playerunmatched
  • Technical Writingunmatched
  • Test Dataunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Validation Documentationunmatched
  • Validation Testingunmatched
  • Writing Skillsunmatched

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