MSAT Product and Process Validation Specialist

GSK•Marietta, PA

1d•Hybrid

About The Position

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.

Requirements

The selected candidate will be hired at the appropriate level based on experience: (grade 8): 2+ years' experience in vaccine/biopharma Incoming Materials (Chemicals and/or SUS) experience, preferably a multinational one.
(grade 7): 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.

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.