BioSpace
Our Fill Finish QA Validation team is hiring. As the QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures. This role will support our Fill Finish facility in Rensselaer, NY.
Equipment
Syringe and Vial Fillers
Lyophilizer
Semi‑Automatic and Automatic Inspection Systems
Assembly Machines
Packaging Machines
Serialization Equipment
Case Packer and Palletizer
Typical Responsibilities
Monitor compliance, analyze failures, and assess corrective actions.
Present project and program status and metrics to Senior Management.
Act as a Technical Subject Matter Expert (SME) in at least one area (e.g., Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control).
Present in a pressure test scenario the technical area they are SME for.
Stay current with industry trends, regulatory requirement updates, and motivate changes and improvements based on trends.
Generate, implement, and/or review master and completed qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Analyze testing results and determine the acceptability of results against pre‑determined criteria.
Review, edit and approve deviation notifications, deviation investigations, and corrective actions.
Review, edit and approve change controls, SOPs, reports and other documentation.
Coordinate with other departments or outside contractors/vendors to complete validation tasks.
Collaborate with functional departments to resolve issues.
Manage and drive projects and prepare status reports.
May present at both internal and external (regulatory) audits.
Who Might Be a Good Fit
Can work independently or as part of a team.
Communicates with transparency.
Gathers and organizes information effectively.
Has effective time management skills.
Looks for continuous improvement opportunities.
Gowning and Environment
Full cleanroom attire (laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and sanitizing agents during gowning).
Can remove jewelry, makeup and nail adornments when wearing cleanroom attire.
Qualifications
Degree: BS/BA in Engineering, Chemistry, or Life Sciences.
Experience: 2+ years as a QA Validation Specialist – 5+ years as a Senior QA Validation Specialist (may substitute proven experience for education).
Salary Range (annually) $66,400.00 – $126,800.00
Benefits Regeneron offers comprehensive benefits that vary by location, including health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves such as military and parental leave.
EEO Statement 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. The company will also provide reasonable accommodation for known disabilities or chronic illnesses of otherwise qualified applicants, unless the accommodation would impose undue hardship on the company’s business operations.
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Equipment
Syringe and Vial Fillers
Lyophilizer
Semi‑Automatic and Automatic Inspection Systems
Assembly Machines
Packaging Machines
Serialization Equipment
Case Packer and Palletizer
Typical Responsibilities
Monitor compliance, analyze failures, and assess corrective actions.
Present project and program status and metrics to Senior Management.
Act as a Technical Subject Matter Expert (SME) in at least one area (e.g., Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control).
Present in a pressure test scenario the technical area they are SME for.
Stay current with industry trends, regulatory requirement updates, and motivate changes and improvements based on trends.
Generate, implement, and/or review master and completed qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Analyze testing results and determine the acceptability of results against pre‑determined criteria.
Review, edit and approve deviation notifications, deviation investigations, and corrective actions.
Review, edit and approve change controls, SOPs, reports and other documentation.
Coordinate with other departments or outside contractors/vendors to complete validation tasks.
Collaborate with functional departments to resolve issues.
Manage and drive projects and prepare status reports.
May present at both internal and external (regulatory) audits.
Who Might Be a Good Fit
Can work independently or as part of a team.
Communicates with transparency.
Gathers and organizes information effectively.
Has effective time management skills.
Looks for continuous improvement opportunities.
Gowning and Environment
Full cleanroom attire (laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and sanitizing agents during gowning).
Can remove jewelry, makeup and nail adornments when wearing cleanroom attire.
Qualifications
Degree: BS/BA in Engineering, Chemistry, or Life Sciences.
Experience: 2+ years as a QA Validation Specialist – 5+ years as a Senior QA Validation Specialist (may substitute proven experience for education).
Salary Range (annually) $66,400.00 – $126,800.00
Benefits Regeneron offers comprehensive benefits that vary by location, including health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves such as military and parental leave.
EEO Statement 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. The company will also provide reasonable accommodation for known disabilities or chronic illnesses of otherwise qualified applicants, unless the accommodation would impose undue hardship on the company’s business operations.
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