Validation Leader

As a Sterile Operations, Validation Leader, you will provide guidance and direction to a team of Validation Professionals supporting the construction, start up, commissioning, and qualification of an R&D, clinical manufacturing, Drug Product filling facility. The new DP facility as well as this position will be located in Marietta, Pennsylvania. After the facility is released for GMP manufacturing, the role will include routine validation support of the facility including, but not limited to: validation maintenance, Change Control management, new equipment / system introduction, decommissioning, and other validation life-cycle requirements.

This role requires consistent and continuous on-site presence. Although the role is based in Marietta, PA, intermittent travel to the existing, clinical, DP manufacturing plant in Upper Merion, PA will be required throughout 2025 and potentially part of 2026.

The Validation Leader has accountability for the successful performance of validation life-cycle activities focused on process equipment, facilities, utilities, analytical equipment and automation systems required for clinical scale, drug product manufacturing

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

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 Lead Sigma ? ADP/ 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 SOP's and other technical documents for process equipment, facilities, and manufacturing processes, as required.
• Assist the technical transfer process to commercial or CMO sites.
• 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 Degree in Mechanical, Electrical or Chemical Engineering or BS/BA in a related scientific discipline (e.g. Chemistry, Biology).

• 2 years in matrix leadership or supervising employees
• 5+ years of relevant technical experience working in a GMP sterile manufacturing (clinical or commercial) manufacturing environment.

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.

#LI-GSK

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 special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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