Are you looking for a more technical role, where you can directly develop, validate, optimize, and maintain robust manufacturing processes? If so, this Senior Process and Validation Specialist/Process and Validation Specialist role could be an exciting opportunity to explore.

As a Senior Process and Validation Specialist/Process and Validation Specialist, you will focus on supporting 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 some of the following areas: vaccine’s raw materials, buffer preparation, single use system, homogenization, complexation, formulation, filtration, aseptic filling, automated visual inspection and/or testing.

This role is essential for ensuring that manufacturing processes and products comply with standards and meet quality requirements. This position focuses on planning, executing, and documenting activities to ensure the consistent production of safe and effective vaccines.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Process

• Provide support to design, tech transfer, validate, and monitor manufacturing and cleaning processes to ensure optimal performance in your area of expertise
• Analyze process data and trends to identify opportunities for improvement and reduce variability.
• Support continued process and cleaning verification (CPV/CV) by tracking critical process parameters (CPPs) and process efficiency through monitoring of manufacturing process parameters (MPPs)
• Support process/product-related improvement programs resulting from Quality, Safety and yield activities.

• Stakeholder Management

• Establish key relationships within the site across Operations, MSAT, Quality, Engineering and EHS. Collaborate with multidisciplinary local teams to balance compliance, cost, and supply risks to arrive at effective and practical solutions

• Training and Development

• Support your peers to ensure other functions have sufficient knowledge in your area of expertise to execute their roles effectively.
• Support the development of standardized training materials with regards to your area of expertise and provide training as required.

• Root Cause Analysis, Continuous Improvement and Support

• Support the operating units to enable routine day-to-day manufacture and resolve technical issues within your scope of expertise.

• Support investigations relating to manufacturing issues, product, process and cleaning performance, and customer complaints using effective deviation management techniques.

• Support process optimization and continuous improvement opportunities using GPS and PLM systems and tools.

• Compliance and Audits:

• Provide necessary support with regards to your area of expertise for all levels of corporate, customer, and regulatory audits.

• Support compliance with regulatory requirements and GSK standards.

• Support the deployment of the standards with respect to your area of expertise to meet business needs.

• Validation

• Support the validation and lifecycle maintenance of process and cleaning, to support site objectives.

• Develop and provide your expertise, ensuring compliance with cGMP.

• Participate in the provision of local Periodic Product Reviews and Validation Plans.

• Support the development of standard validation processes and roll-out and adherence to these processes.

• Other
• Ensure that EHS, Sustainability and GPS are supported.

Why you?

Basic Qualifications:

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

• Bachelor’s Degree
• Minimum of 2 years in vaccine pharmaceutical process and/or validation experience, preferably a multinational one.

Preferred Qualifications:

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

• Knowledge and understanding of vaccine’s raw materials, single use system, filtration, homogeneity, complexation, buffer preparation, formulation, aseptic filling, automated visual inspection and/or testing.
• Experience with investigational techniques, too