Cleaning Validation Engineer SME

Job Title: Cleaning Validation Engineer SME

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.

Position Summary:
Join GSK as a Cleaning Validation Engineer SME and play a key role in ensuring our manufacturing processes meet the highest standards of cleanliness and compliance ensuring the Zebulon site cleaning validation is maintained in audit ready "state" and meets all local and global regulatory requirements. In this role, you will develop and implement cleaning validation strategies, collaborate with cross-functional teams, and contribute to the continuous improvement of our operations. We value candidates who are detail-oriented, proactive, and passionate about making a meaningful impact. This is an opportunity to grow your career while supporting GSK's mission to unite science, technology, and talent to get ahead of disease together.

Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Design and manage Cleaning Validation activities at the site following a Lifecycle Approach including the authoring of Cleaning Validation Protocols and Reports.

• Lead Cleaning Risk Assessments related to new product introduction and changes to existing products, materials, processes and systems.

• Design, plan and execute cleaning trials, analyze results and provide technical assessment, conclusions and recommendations.

• Author and maintain the Cleaning Validation Master Plan for the Site.

• Lead the periodic cleaning validation monitoring at the site.

• Benchmark against broader GSK GMS and external industry with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network to achieve excellence in Cleaning Validation.

• Participate on assigned teams as required to provide Cleaning Validation Impact Assessments and guidance.

• Review and coordinate Change Controls with Cleaning Validation impact as required.

• Lead and support continuous improvement by identifying and implementing projects to eliminate waste and improve cleaning times.

• Participate in teams to present Cleaning Validation documentation during Internal and External Regulatory inspections and prepare responses to deficiency reports.

Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in engineering, chemistry, microbiology, or a related field.

• 5+ years of experience in cleaning validation within a regulated manufacturing environment.

• knowledge of cleaning validation principles, regulatory guidelines, and industry standards.

• Experience with risk assessments and validation documentation.

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

• Advanced degree in a relevant field.

• Familiarity with lean manufacturing and continuous improvement methodologies.

• Previous experience supporting regulatory audits and inspections.

• Strong organizational skills and ability to manage multiple projects simultaneously.

• Passion for innovation and driving process improvements.

• Excellent problem-solving skills and attention to detail.

• Effective communication and collaboration skills to work across teams.

This role is on-site and offers the opportunity to work in a dynamic and collaborative environment. If you're ready to make a difference and grow your career, we encourage you to apply today!

#LI-GSK

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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