Validation Engineer - Project Leader

GSK•Upper Merion Township, PA

1d•Onsite

About The Position

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.

Requirements

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).

Nice To Haves

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.

Responsibilities

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.