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 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 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 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:

• 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 5+ 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.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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.

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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.

Ready to apply?
If this role fits your skills and aspirations, we want to hear from you. Please submit your resume and a short note describing a recent validation or qualification project you led or supported. We look forward to learning about you.

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

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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