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Principal QA Validation Specialist-(Small Equipment)

Job Description

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Provide technical leadership and guidance for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with cGxP, regulatory requirements and industry trends.

Supervise the End-To-End qualification process ensuring each piece of equipment fits for the intended use, contribute to 365 inspection readiness program, and follow, foster and implement on daily basis a quality culture and any other company manufacturing standards, policies and procedures.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Strong knowledge and understanding of equipment used for QC analysis and operations.

  • Strong background and familiar with site change control, risk management and data integrity initiatives/programs.

  • Strong knowledge and understanding of EU annex 11 and FDA 21 CFR Part 11.

  • Previous experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits.

  • Schedules, executes and reviews/approves qualification activities.

  • Assess executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.

  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

  • Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions.

  • Reviews, edits, and approves change controls, SOPs, reports and other documentation.

  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.

  • Collaborates with functional departments to resolve issues.

  • Manage and drives projects and prepares, reviews, or approves status reports.

  • Supervise, provide direction and assign work to less experienced full-time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlines.

  • Stays current with industry trends, regulatory requirement updates, and communicating same to team.

  • Performs other duties assigned by management.

  • Some travel may be required.

Education and Experience:

  • BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field preferred; may substitute relevant experience for education.

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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.