MSAT; Senior Product and Process Validation Specialist

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024, helping to make a positive impact on the health of millions of people. Our supply chain is vital to bringing innovations to patients as quickly, efficiently, and effectively as possible.

Technology is transforming how we manufacture, enabling us to increase the speed, quality, and scale of product supply. We need the very best minds and capabilities to help us on our journey to make more complex products, harnessing smart manufacturing technologies, including robotics, digital solutions, and artificial intelligence to deliver for patients.

GSK's Marietta, PA site is a hub for biopharmaceutical manufacturing, quality, and R&D, supported by engineering, supply chain, and EHS teams that ensure safe, compliant, and efficient operations. Employees enjoy a collaborative culture with strong training and development programs, opportunities for career growth, emphasis on safety and quality, and active community engagement—enabling you to make a meaningful impact on patient health.

Today, the site is undergoing a transformation to increase size and capacity and add state‑of‑the‑art facilities for drug substance, drug product, and R&D. This expansion brings advanced digital and automation technologies, alongside sustainability features. Looking forward, the development positions Marietta as a modern, end‑to‑end innovation hub delivering next‑generation vaccines and medicines for global health.

If you are looking for a role that allows you to leverage your technical knowledge in a state‑of‑the‑art manufacturing environment, this MSAT (Senior) Product and Process Validation Specialist role could be an ideal opportunity to explore.

As an MSAT (Senior) Product and Process Validation Specialist, you will develop, validate, optimize, and maintain robust manufacturing processes in our vaccine production facility. Your work ensures process efficiency, consistency, and compliance with regulatory and quality standards involved in new product introduction, technical transfers, validation lifecycle, troubleshooting, continuous improvement initiatives, and cross‑functional collaboration to support the production of high‑quality, safe, and cost‑effective vaccines in line with Site, GSK, and regulatory requirements.

This includes activities in incoming material (chemical and single‑use systems), homogeneity, cross‑contamination control, cleaning, buffer preparation, complexation, formulation, filtration, aseptic filling, automated visual inspection, and/or testing.

This position focuses on planning, executing, and documenting activities in your area of expertise to ensure consistent production of safe and effective products. It is essential for ensuring that manufacturing processes and products comply with standards and meet quality requirements and is a great opportunity for someone who enjoys technical problem‑solving, cross‑functional collaboration, and working at the interface of science and operations.

• Lead/Support design, tech transfer, and qualification of Incoming Materials (Chemicals and Single Use Systems), including Extractable and Leachable Assessments.
• Drive Incoming Material Qualification and Validation and lead/support lifecycle maintenance to ensure manufacturing processes are capable of consistently producing high quality products.
• Provide technical expertise to Periodic Reviews, Validation Plans and Supplier Change Notifications and support their implementation and compliance.
• Manage vendors for Incoming Materials to achieve project deliverables.
• Set up and perform Process Confirmations to verify that control strategies are implemented as designed.
• Assist the operating units with routine day‑to‑day manufacturing activities by providing support within your scope of expertise.
• Lead/Support investigations, deviations, root‑cause analysis, CAPA, complaints and gaps assessment for product, process…