Senior Quality Assurance Validation Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Senior QA Validation Specialist, you will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & Where Location: Rensselaer, New York, United States Monday-Friday, 8am-4:30pm What Youll Do Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria Analyzes the results of testing and determines the acceptability of results against pre-determined 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 Executed real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials Conducts temperature mapping for controlled environments and distribution lanes Programs and deploys instrumentation to capture vibration and shock profiles; analyzed data to inform packaging design and handling recommendations Programs humidity and pressure sensors and interpreted datasets to support test plans and root-cause analysis Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification Performs small-parcel and palletized-load qualifications, including test planning, execution, and reporting Gowning And Environment Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA) Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire Lets Find Out If Were a Fit Requires B.S in life sciences or related field; may substitute proven experience for education requirement QA Validation Specialist: 4 + years of experience Sr. QA Validation Specialist: 6+ years of experience Level will be determined based on experience Thrive today. Grow tomorrow. Student loan paydown program & tuition reimbursement Family care benefits Relocation assistance Inclusion, culture and well-being programs (including physical & mental health) Salary Range (annually) $67,400.00 - $128,700.00 We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. #J-18808-Ljbffr BioSpace