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Valspec

Computer system validation and lifecycle services

Validation Engineer

Regulatory & Quality (Life Sciences)Updated on Nov 10
Full-timeEl Segundo, CA, USA

About the Job

Requirements

  • Requires 2–4 years of validation experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or similar regulated manufacturing environments.
  • Requires Equipment Validation (CQV) experience within a life sciences manufacturing environment.
  • Requires direct experience authoring and executing validation protocols.
  • Requires experience generating IQ/OQ/PQ documentation, validation summary reports, and protocol exceptions.
  • Requires a strong understanding of current Good Manufacturing Practice (cGMP) documentation requirements.
  • Requires experience scheduling and executing qualification activities.
  • Must be legally eligible to work in the United States without company sponsorship.

Responsibilities

  • Execute commissioning, qualification, and validation activities for Good Manufacturing Practice (GMP) facilities and manufacturing systems.
  • Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
  • Generate validation protocols, summary reports, deviations, and protocol exceptions.
  • Support qualification of facility systems, cleanrooms, heating, ventilation, and air conditioning (HVAC) systems, and GMP utilities.
  • Schedule, coordinate, and execute qualification activities with cross-functional project teams.
  • Review commissioning documentation and ensure readiness for qualification testing.
  • Participate in project meetings as the commissioning, qualification, and validation (CQV) representative.
  • Maintain GMP-compliant validation documentation.
  • Support startup, troubleshooting, and system turnover activities.
  • Work directly in manufacturing and facility environments with significant field presence.

Desired Qualifications

  • Facility Qualification experience.
  • HVAC Qualification experience.
  • Cleanroom Qualification experience.
  • Utility Qualification experience, including water for injection (WFI), purified water, clean steam, compressed air, and process gases.
  • Experience supporting aseptic manufacturing, fill-finish, biotechnology, or sterile processing environments.
  • Familiarity with ASTM E2500 and modern CQV methodologies.
  • Ability to work independently in a highly collaborative project environment.

About the Company

Valspec

Computer system validation and lifecycle services

Valspec provides validation, testing and qualification services for manufacturing automation and IT systems used in making drugs. It covers the full system life cycle, from commissioning to qualification and ongoing validation, ensuring computer systems and manufacturing equipment perform correctly and compliantly. Its offerings help life sciences companies meet regulatory and quality goals, optimize production and support development of therapies. Valspec differentiates itself by deep plant automation and engineering expertise, a track record of supporting projects that bring life-changing drugs to market and improve production efficiency, and a focus on pairing passionate engineers with projects that require rigorous validation and lifecycle services. The company’s goal is to help clients deliver reliable, compliant manufacturing systems and therapies to patients while enabling cost-effective production and faster access to medicines.

Company size
51-200
Company stage
Not listed
Total funding
Not listed
Headquarters
Royersford, PA
Founded
Not listed

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