Validation Engineer

GSK is currently looking for a Validation Engineer to join our team in Upper Merion, PA. In this role, 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.

KEY RESPONSIBILITIES:

• 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.

Basic Qualifications:

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

• BS/BA Degree
• 2+ years of GMP experience

Preferred Qualifications:

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

• BS Degree in Engineering is preferred
• 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.

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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