MSAT Senior Product and Process Validation Specialist

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 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.

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.

About the Role

As a 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. This 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. Key areas include:

• 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.

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 peers in your area of expertise to ensure other functions have sufficient knowledge to execute their roles effectively and develop standardized training materials.
• Partner with Site Operations, Quality, Engineering, Supply Chain, MSAT SMEs, and Global teams to deliver compliant, practical solutions.

Requirements

• 5+ years' experience in vaccine/biopharma Incoming Materials (Chemicals and/or SUS), preferably in a multinational environment.
• 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.

Preferred Qualifications

• 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 and tools for process investigations and troubleshooting.

What We Value in You

We put safety and quality first. We look for people who are curious, open to learning, and willing to share knowledge. You will join a team that collaborates across roles and helps improve how we work. We welcome applicants from all backgrounds and encourage people who bring different perspectives to apply.

Work Arrangement

This position is on-site in the United States. Performance with choice: 3 days on-site minimum, 2 days remote based on workload or projects. This can change based on team needs or performance.

Benefits

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Skills

• CMC Strategy
• Data-Driven Decision Making
• Data Integrity
• Debate Moderation
• Digital Fluency
• GxP Regulations
• Lean Management
• Problem Solving
• Process Optimization
• Project Leadership
• Risk Awareness
• Scientific Writing
• Technology Transfer