Validation Engineer

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

As a Validation Engineer, you will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, scheduling and executing testing, gathering and analyzing data, and writing validation summary reports. This person will participate as a supporting member representing validation on project teams. Validation Engineers will lead specific validation projects.

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

• Design required validation studies and write protocols for the facility and equipment.

• Coordinate resources required to complete validation studies in a timely manner.

• Execute validation studies per required schedules in a safe, compliant manner (e.g. LOTO).

• Analyze test data and report questions/issues. Lead and document investigations of failed validation test results.

• Complete validation protocols and validation summary reports with necessary approvals.

• Support the review of new systems and modifications to existing systems to ensure designs comply with cGMPs and are able to be validated and maintained in a validated state.

• Maintain validation equipment and supplies to enable validation to be completed per schedule requirements.

• Support the development of required validation procedures and practices with respect to the facility.

• Identify issues and/or improvements to validation procedures, practices, and policies related to validation, equipment and processes.

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

• Associates degree with 2 + years with biotech or pharma experience

• OR BS/BA degree with 1+ year of experience with biotech or pharma

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

• Familiar with cGMPs.

• Strong interpersonal and organizational skills.

• Technical understanding of the industry and validation practices related to the pharmaceutical industry is preferred.

• Strong verbal and written communication skills.

• Must be able to interact well with peers and senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines.

• Able to take directions and effective at implementing decisions.

• Must have strong technical writing skills.

• 1+ years of process engineering or validation engineering experience with biotech or pharma

• understanding how to read or process P&ID

• Working with Kneat

• SIP and CIP validation experience

• Familiarity with Lock out tag out

• Prior experience with Kaye Software in temperature mapping

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 GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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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