Validation Engineer - Project Leader

As a Validation Engineer - Project Leader, working within the Clinical Sterile Operations pilot plant, you will be responsible for the successful delivery of validation life-cycle documents associated with direct impact clinical GMP manufacturing process equipment, clinical manufacturing facility, critical utility systems, and automation systems required for clinical scale, drug product manufacturing. Additional responsibilities include the qualification of microbiology and analytical systems and instrumentation that support clinical GMP drug product manufacturing operations.

The Validation Engineer - Project Leader, has the responsibility of ensuring all validation life-cycle activities are performed in compliance with GSK validation life-cycle policy and procedures.

This position will initially be located at the GSK's Upper Merion site in Upper Merion, Pennsylvania from 2026 to 2028, and will permanently move to Marietta, Pennsylvania afterwards. Although the role is based in Upper Merion, PA, intermittent travel to the new clinical drug product manufacturing facility in Marietta, PA, will be required between 2026 and 2028. This role requires consistent and continuous on-site presence.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Ensure validation life-cycle activities are performed in compliance with relevant GSK policies and procedures.

• Collaborate with direct GSK staff and third-party personnel engaged in drafting validation documents, execution of validation studies, completion of reports / validation life-cycle deliverables, commissioning (where applicable) and start-up, and routine validation during the system/equipment lifecycle.

• Create and update validation project plans and timelines.

• Subject Matter Expert (SME) representative for quality management document impacting validation, sterilization, cleaning or sterile operations within R&D.

• Oversee and manage all validation activities including change management, ensuring all activities are performed following application GMP and GSK procedures.

• Support quality investigations, ensure appropriate CAPA are developed and implemented as agreed.

• Support internal and external audits and ensure follow-up audit actions are completed as agreed.

• Coordinate routine validation activities with owner, maintenance and engineering.

• Develop, maintain and optimize validation processes using Lean Sigma / continuous improvement methodologies.

• Represent Sterile Clinical Manufacturing team on global technical focus and communities of practice.

• Lease with the global pilot plant network for knowledge sharing and best practice regarding sterile assurance.

• Manage, write, review and approve validation life cycle SOPs and other technical documents for process equipment, facilities, and manufacturing processes, as required.

• Assist the technical transfer process to commercial or CMO sites, as required.

• Provide technical support for the implementation of novel manufacturing technologies.

• Provide leadership and oversight for site validation programs and initiatives.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in Mechanical, Electrical or Chemical Engineering, or BS/BA in a related scientific discipline (e.g. Chemistry, Biology).

• 5+ years of relevant technical experience in a validation capacity working in a GMP biopharmaceutical or sterile manufacturing environment (clinical or commercial).

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience with any of the following: Isolator, Lyophilized, External Vial Washer, autoclaves, aseptic filling desired.

• Ability to work in a complex, multi tasking environment across local and functional teams.

• Ability to organize and effectively lead multiple diverse, cross-functional teams.

• Comprehensive knowledge of pharmaceutical systems qualification requirements and quality compliance. (GMP,ICH, FDA, US, EP, JP, etc.).

• Basic knowledge of aseptic techniques and sterility assurance requirements related to aseptic processing / terminal sterilization and validation of manufacturing equipment use for aseptic manufacturing.

• Basic knowledge of microbiology as it relates to cleanroom environments and aseptic processing / sterile manufacturing.

• Excellent communication and interpersonal skills; commitments to transparency; ability to build consensus and effectively negotiate resolution to complex technical and business issues.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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