Senior Validation Engineer
Gsk•21h ago
United StatesOnsiteFull-timeSenior Level5+ yrs exp
H-1B sponsor
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: This role will be responsible for understanding modern computer systems and control/digital systems within the facility. It is important for the individual to have a background that will enable appropriate decision making to ensure the success of the facility.
You will lead and execute validation projects for equipment, facilities, utilities, and computerized systems. You will write and review validation protocols, run or supervise testing, analyze results, and author final reports. You will work closely with engineering, quality, operations, and IT teams.
We value practical problem solving, clear communication, and a focus on continuous improvement. This role offers growth, visible impact on regulated manufacturing, and alignment with our mission of uniting 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: Lead validation test activities, collect and analyze data, and drive timely resolution of deviations.
- Plan, write, and execute validation protocols and final reports for equipment, utilities, facilities, and computerized system.
- Coordinate cross-functional teams, vendors, and contractors to meet project timelines.
- Maintain and update validation project plans and the Site Validation Master Plan.
- Mentor and coach junior validation staff to build capability and consistency in execution.
- Support audits and regulatory inspections by preparing documentation and responding to findings.
- Oversee the development of, and participate in, required validation studies and protocols for analytical equipment and computer systems and lead the effort to approve protocols and associated reports.
- Assist and guide the development of specification documentation to ensure it complies with current validation standards and QMS methodologies, and systems are able to be adequately validated.
- Development of procedures, practices, and policies related to computer system validation.
- Monitor and update the Validation Master Plan to ensure that it complies with appropriate regulatory guidelines and standard practices.
- Provide leadership in setting priorities, fulfilling customer needs, defining timelines, and tracking projects.
- Ensure team deliverables are met within defined timelines.
- Interface with other departments to coordinate resources and complete validation activities in a timely manner.
- Development of Validation Project Plans to support major changes to the site and develop the team to become proficient in validation activities (e.g. analytical equipment qualification and computer system validation)
Basic Qualifications
- We are seeking professionals with the following required skills and qualifications to help us achieve our goals. 8+ years of relevant technical experience with a minimum 5 + years’ hands-on validation experience in a regulated environment (equipment, facility, utilities
- computerized systems).
- Bachelor’s degree in engineering, life sciences, computer science, or a related technical field or associate's degree in engineering, life sciences, biology with 8 plus years of technical experience.
- Experienced required with hardware, software, specifically, Microsoft Windows operating system settings and configuration, process control systems, databases, writing and executing IQ, OQ, PQ or equivalent validation protocols
Preferred Qualifications
- If you have the following characteristics, it would be a plus: Advanced degree in engineering, life sciences, or related discipline.
- Experience leading projects or supervising small technical teams.
- Experience with computerized system validation, including lifecycle documentation and 21 CFR Part 11 concepts.
- Familiarity with commissioning and qualification of utilities and automation systems.
- Training in Lean, Six Sigma, or continuous improvement methods.
- Strong interpersonal skills and experience working with cross-functional stakeholders.
- What we offer: You will join a team focused on meaningful work and continuous learning.
- You will gain visibility through high-impact projects and expand your technical and leadership skills.
- If you want to grow your career while helping deliver high-quality, compliant operations, we want to hear from you.
- Apply now and tell us how your experience can help the team move forward.
- We encourage applications from people with diverse backgrounds and experiences who value inclusion and teamwork. #LI-GSK #GSKCareers Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
- 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
- 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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Required skills
validationMicrosoft Windowsprocess control systemsdatabasesIQOQPQ