Validation Engineer II

Your Impact

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.

Position Summary

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.

Responsibilities

These may include but are not limited to:

• 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.

Requirements, Knowledge, Skills and Abilities

• 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. We will consider an equivalent combination of education and experience.
• 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.
• This role may require extended periods of sitting and/or standing, with work performed in an office, manufacturing cleanroom (ISO 5/7), or clinical environment.

Validation Engineer II Pay Rate: $80,500 to $149,500

The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.

Who We Are:

Poseida Therapeutics was acquired by Roche in early 2025 and is now part of the Roche Group. Poseida is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral DNA Delivery System, Cas-CLOVER Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing.

Our people are as important as our cutting-edge technology. That's why we invest in offering excellent career development opportunities to our employees, as well as highly competitive compensation and comprehensive benefits. We are committed to giving employees the resources they need to thrive, personally and professionally.

Within the Roche organization, a healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.