Job Title: Senior Validation Engineer Job Location: King of Prussia, Pennsylvania, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Please note that this is a ‘internal job posting’ link, intended for GSK/ViiV employees only. Contingent Workers should check with the recruiter of the Job Requisition to confirm whether the job is open to contingent workers and to obtain the correct job posting hyperlink. Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines.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 equipment/facility/computer 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 leading team member representing validation on project teams.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, or 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.Work Arrangement: This position is completely onsite and does not offer hybrid or work from home arrangements.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#GSKCareersSkillsData Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Problem Solving, Project Management, Quality Assurance (QA), Risk Awareness, Technical Writing, Validation Processes If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please submit a request to HR via the Service PortalGSK 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.This Position Description is to provide a framework for job understanding between employee and manager. It may not cover or contain the full listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice and at the discretion of the management of the Company. The position description is not used in the assignment or assessment of any GSK level or grade used in the Job Evaluation Process.Compensation Grade:7Job Posting End Date:Not AvailableEligible for Employee Referral Bonus:YesThis job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Job Title: Senior Validation Engineer

Job Title:

Job Location: King of Prussia, Pennsylvania, United States of America

Job Location:

Job Location Type: Remote

Job Location Type:

Job Contract Type: Full-time

Job Contract Type:

Job Seniority Level:

Job Seniority Level:

Please note that this is a ‘internal job posting’ link, intended for GSK/ViiV employees only. Contingent Workers should check with the recruiter of the Job Requisition to confirm whether the job is open to contingent workers and to obtain the correct job posting hyperlink.

Please note that this is a ‘internal job posting’ link, intended for GSK/ViiV employees only. Contingent Workers should check with the recruiter of the Job Requisition to confirm whether the job is open to contingent workers and to obtain the correct job posting hyperlink.

Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines.

Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines.

Business Introduction:

Business Introduction: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:

Position Summary:Position Summary:

This role will be responsible for equipment/facility/computer 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 leading team member representing validation on project teams.

Responsibilities:

Responsibilities: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.

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.

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.

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.

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.

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.

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.

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).

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:

Basic Qualifications: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, or computerized systems).

8+ years of relevant technical experience with a minimum 5 + years’ hands-on validation experience in a regulated environment (equipment, facility, utilities, or 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.

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.

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:

Preferred Qualifications:Preferred Qualifications:

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

• Advanced degree in engineering, life sciences, or related discipline.

Advanced degree in engineering, life sciences, or related discipline.

• Experience leading projects or supervising small technical teams.

Experience leading projects or supervising small technical teams.

• Experience with computerized system validation, including lifecycle documentation and 21 CFR Part 11 concepts.

Experience with computerized system validation, including lifecycle documentation and 21 CFR Part 11 concepts.

• Familiarity with commissioning and qualification of utilities and automation systems.

Familiarity with commissioning and qualification of utilities and automation systems.

• Training in Lean, Six Sigma, or continuous improvement methods.

Training in Lean, Six Sigma, or continuous improvement methods.

• Strong interpersonal skills and experience working with cross-functional stakeholders.

Strong interpersonal skills and experience working with cross-functional stakeholders.

Work Arrangement:

Work Arrangement:Work Arrangement:

This position is completely onsite and does not offer hybrid or work from home arrangements.

What we offer:

What we offer: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

Skills

Skills

If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please submit a request to HR via the Service Portal

Service Portal

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.

This Position Description is to provide a framework for job understanding between employee and manager. It may not cover or contain the full listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice and at the discretion of the management of the Company. The position description is not used in the assignment or assessment of any GSK level or grade used in the Job Evaluation Process.

Compensation Grade:

Compensation Grade:Compensation Grade:Compensation Grade:Compensation Grade:

Job Posting End Date:

Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:Job Posting End Date:

Eligible for Employee Referral Bonus:

Eligible for Employee Referral Bonus:Eligible for Employee Referral Bonus:Eligible for Employee Referral Bonus:Eligible for Employee Referral Bonus:

This job is curated by Lifelancer.

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.