MSAT Product and Process Validation Specialist

GSK•Marietta, PA

3d•Hybrid

About The Position

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. About the Marietta Site 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 — all enabling you to make a meaningful impact on patient health. Are you looking for an MSAT Senior Product and Process Validation Specialist role that allows you to leverage your technical knowledge in a state-of-the-art manufacturing environment? If so, this MSAT Senior Product and Process Validation Specialist role could be an ideal opportunity to explore. Position Summary As a MSAT 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 which involves 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, especially in the following areas: incoming material (chemical and single use system), 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 the consistent production of safe and effective products. This role 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Requirements

2+ years' experience in vaccine/biopharma Incoming Materials (Chemicals and/or SUS) experience, preferably a multinational one.
Bachelor Degree of Science, Post Graduate Degree of Science or equivalent experience in a related scientific or technical discipline such as chemical/biological engineering, pharmacy, or pharmaceutical engineering.
Experience with technical writing and executing technical protocols, reports and standards.
Knowledge of applicable regulatory requirements for Incoming Materials e.g. USP 665, USP 1665, USP 661, EP, Ch. P etc.
Experience with risk-based approaches, design of experiments and process performance qualification strategies.

Nice To Haves

Master Degree of Science, or PhD
Experience in pharmaceutical or biologics manufacturing environment.
Experience with Incoming Materials (Chemical and SUS) introduction i.e. qualification and validation.
Working knowledge of production equipment, utilities, and automation used in manufacturing.
Experience using quality systems such as change control, CAPA, and deviation management.
Strong communication skills with the ability to work across functions.
Demonstrated problem-solving skills and experience with investigational techniques, tools for process investigations and troubleshooting.

Responsibilities

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 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 investigations, deviations, root-cause analysis, CAPA, complaints and gaps assessment for product, process and incoming material performance issues.
Support audits (corporate, customer, regulatory) and ensure compliance with internal and external standards.
Lead process optimization and continuous improvement initiatives by utilizing GPS tools under guidance.
Support in your peers in your area of expertise to ensure other functions have sufficient knowledge to execute their roles effectively and the development of standardized training materials to provide training as required.
Partner with Site Operations, Quality, Engineering, Supply Chain, MSAT SMEs and Global teams to deliver compliant, practical solutions.