Principal QA Validation Specialist; Fill​/Finish

Principal QA Validation Specialist (Fill/Finish) – Bio Space

Our QA Fill Finish Validation team is hiring a Principal QA Validation Specialist to validate and qualify equipment, systems, and processes in compliance with regulatory standards. Support our newly constricted Fill Finish Facility in Upstate NY and contribute to a fast-paced, innovative environment.

In this role, a typical day might include the following:

• Lead validation efforts for equipment, processes, and systems (including IQ, OQ, PQ).
• Act as a Technical SME (Subject Matter Expert) in areas including Equipment Qualification, Drug Product Filling Validation, and Automated/Semi-Automated Visual Inspection.
• Validate equipment such as Syringe/Vial Fillers, Inspection Machines, Packaging Machines, and Finished Goods handling systems.
• Must be able to present in a pressure test scenario the technical area they are SME for.
• Generate, review, and approve master and complete qualification validation protocols, reports, SOPs, and change controls.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• May present at both internal and external (regulatory) audits.

• Have expertise in validation processes including automated/semi-automated visual inspection and finished goods handling.
• Ability to communicate with transparency.
• Continuously aim to improve processes for improved performance.
• Have strong communication, time management, and problem-solving skills.

To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and the following years of experience for each level:

• Sr QA Validation Specialist: 5+ years
• Principal QA Validation Specialist: 8+ years
• Staff QA Validation Specialist: 10+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Salary Range (annually): $77,600.00 - $

• Mid-Senior level

• Full-time

• Quality Assurance

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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, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Background checks may form part of the recruitment process in accordance with the law of the country where the position is based.

Location:

East Greenbush, NY (Upstate NY facility).