Sterility Assurance 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.

Position Summary
As a Sterility Assurance Specialist, you will be Subject Matter Expert (SME) for development, implementation, monitoring and improvement of Sterility Assurance Programs at the Marietta Site location.

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

• Responsible for improving sterility assurance program at Marietta and sharing sterility assurance best practices between Marietta and other GSK aseptic manufacturing sites.

• Evaluate manufacturing operational practices and strategies to ensure compliance with regulatory requirements. Lead, develop, implement, influence changes to meet requirements and continuously improve sterility assurance processes.

• Responsible for aseptic process simulations, facility cleaning, material transfer, aseptic behavior, Environmental Monitoring, gowning and contamination control strategy programs. Provide oversight and measure effectiveness of Sterility Assurance programs. Maintain and improve LSOPs (local procedures) for these programs and perform periodic review of local procedures (for example- facility cleaning, aseptic behaviors, material transfer, gowning, EM and aseptic simulations). 

• Responsible for trending, generating Environmental Monitoring trend reports and ensuring that Environmental Monitoring and gowning programs are in control. Responsible for all rationale documents and risk assessments to support the environmental monitoring and gown monitoring programs.

• Provide expert advice when changes to classified environments are proposed to evaluate the benefits or disadvantages of the proposed changes and to assist with investigation of excursions. Provide trending data analysis to assist with the evaluation of the impact of excursions. Ensure that the site monitoring strategy for classified areas complies to procedures and external regulatory expectations.

• Interface directly with domestic and foreign regulatory inspectors regarding microbiological and sterility assurance topics.  

• Participate in the investigation and planned remedial actions for out of compliance EM / Sterility Assurance results in order to support the timely resolution of investigations.

• Own and execute quality system (CAPA, Change Control, LSOP revisions, gap analysis).

• Responsible for training, coaching, and qualification program for aseptic techniques, clean room behaviors, and gowning.

• Provide technical guidance for all questions and issues related to sterility assurance topics and support 3 shifts of operation, as required.

• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

Why You?

Work arrangement
This role will require 100% on site responsibilities and is not a Hybrid position.

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

• Bachelor’s degree in microbiology, biology, pharmacy, or related scientific discipline.

• 5+ years pharmaceutical industry experience.  GMP/Microbiology/Quality or Aseptic Area role to include direct work with environmental monitoring of aseptic filling operations and sterility assurance systems.

• Technical expert in sterility assurance process, environmental monitoring and gown monitoring programs.

• Knowledge of microbiology, contamination control programs to implement and improve cleaning, gowning, aseptic behaviors, material transfer, aseptic simulations and environmental monitoring programs.

• Experience leading investigations, deviations, or microbiological problem solving.

• Ability to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.

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

• Master’s degree  in biology or microbiology, pharmaceutical sciences, or related field.

• Advanced practical knowledge of aseptic process simulations, cleaning, gowning, aseptic behaviors, material transfer and environmental monitoring programs required to influence decision making, regulators and stakeholders.

• Experience supporting regulatory inspections and preparing regulatory responses.

• Knowledge of sterility assurance principles, USP chapters, and cleanroom standards.

• Experience with aseptic process validation and gowning practice oversight.

• Familiarity with electronic quality management systems for investigations and CAPAs.

• Strong technical writing skills to produce clear, audit-ready documentation.

• Ability to work collaboratively and escalate issues when needed.

• Champion change and innovation, drive execution and results, motivate others and foster collaboration at all levels of the site.

• The ability to drive site objectives and results; work in a fluid environment; drive culture & lead department initiatives.

• Demonstrated interpersonal and leadership skills. 

• The ability to function and influence within team-based organization.

What we value in you
We want people who are curious, accountable, and open to learning. You should be comfortable working with data and translating findings into action. We welcome different perspectives and promote inclusion in our teams. If you care about doing precise, meaningful work that protects patients, please apply.

How to apply
Please submit your resume and a short note describing a recent investigation or improvement you led. Tell us the issue, your approach, and the outcome. We look forward to learning how you can help us deliver high quality results for patients and grow your career at 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

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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