GSK · 23 hours ago
Validation Engineer - Project Leader
USA - Pennsylvania - King of Prussia
Full-time
Onsite
Senior Level
5+ years expGSK is a global biopharma company focused on uniting science, technology, and talent to advance health. As a Validation Engineer - Project Leader, you will oversee validation life-cycle documents for clinical GMP manufacturing processes, ensuring compliance with GSK policies and managing validation activities across various systems and facilities.
BiotechnologyHealthcarePharmaceuticalHealth Care
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
Qualification
Required
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
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
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Luke Miels
Chief Executive Officer
Julie Brown
CFO
Recent News
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2026-02-05
2026-02-03
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