Poseida Therapeutics-posted 3 months ago
$80,500 - $149,500/Yr
Mid Level
San Diego, CA
Professional, Scientific, and Technical Services

Join our mission to cure cancer. We are seeking a driven and technically skilled Validation Engineer to become a vital part of our team. In our fast-paced, cGMP aseptic manufacturing facility, you will be a critical force in ensuring the equipment and systems that produce our life-saving therapies meet the highest standards of quality and compliance. If you are passionate about applying your validation expertise to make a tangible impact on the lives of patients, we want to hear from you. In this role, you will apply your deep knowledge of IQ, OQ, and PQ processes to qualify equipment and software that support both routine operations and the introduction of new product lines. This includes drafting and managing documentation for GMP and GDP compliance, where your integrity and attention to detail will be crucial for audit readiness. As a collaborative problem-solver, you will partner with cross-functional groups, including IT, QA, Manufacturing, and Process Development—to validate all GxP equipment and systems.

  • Develop, author, and execute validation protocols (IQ, OQ, PQ), specification documents (URS, FRS, CS), and summary reports for a wide range of manufacturing, facility, and laboratory equipment and computer systems in our aseptic fill/finish manufacturing facility.
  • Review validation protocols and reports, and provide technical input for validation deviations, investigations, and change control assessments.
  • Experience developing and executing equipment impact assessments and validation protocols, and reports for production facilities and equipment in a pharmaceutical cGMP-regulated environment.
  • Conduct engineering studies and risk assessments to characterize equipment performance, define validation requirements, and support investigations.
  • Coordinate and collaborate with cross-functional teams to align validation and compliance efforts, ensuring all qualification and validation activities meet established requirements.
  • Assume responsibility for the timely completion of projects or assigned work, ensuring activities are consistent with the project's critical path and responding appropriately to changing priorities.
  • Identify opportunities to enhance validation practices, improve efficiency, and ensure documentation is consistently audit-ready.
  • Effectively communicate timelines, risks, and support needed to align all functions to achieve desired project goals.
  • Coordinates validation testing schedules with cross-functional teams to minimize disruption to manufacturing operations.
  • Bachelor's degree in an Engineering, Engineering Technology, or Life Science discipline.
  • 3+ years of relevant industry experience, equipment qualification, or computer system validation within a cGMP environment.
  • Direct experience in a biotech or pharmaceutical manufacturing environment is required; experience in an aseptic/sterile facility is highly preferred.
  • Expert knowledge of validation principles, system implementation, and quality systems (Change Control, Deviations, CAPA) in a GMP environment.
  • Understanding of 21 CFR Part 11, cGMP, and other FDA/EU regulations for manufacturing equipment and automated systems.
  • Ability to interpret technical documentation, including engineering specifications and process flow diagrams.
  • Proven ability to author, review, and execute high-quality technical and validation documentation.
  • Excellent written and verbal communication skills, with a strong attention to detail.
  • Demonstrated ability to lead projects, solve complex problems, and think critically.
  • A proactive and collaborative mindset with the ability to work effectively both independently and as part of a team.
  • Excellent career development opportunities
  • Highly competitive compensation
  • Comprehensive benefits
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