Senior Quality Assurance Validation Specialist (Oversight)

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 Sr. QA Validation Specialist, you will support validation of equipment, utilities, software, cleaning and sterilization processes at our facility in accordance with regulatory requirements by implementing company manufacturing standard 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 Investigation and troubleshooting problems which occur during validations and determines solutions or recommendation for changes and/or improvements Coordinates with functional department to resolve issues from validations Reviews, edits and approves deviation notifications, deviation investigations and corrective actions Coordinates with other departments or outside contractors/vendors to complete validation tasks Develop tracking mechanism of validation activity completion for various projects and prepare status report Present validation project and program status reports to senior management on a routine basis Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing Stays current with industry trends, regulatory requirement updates and communicating to teams May present at both internal and external (regulatory) audits 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)

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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. for more information about onsite expectations for your role and location. 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. Salary Range (annually) $67,400.00 - $128,700.00 #J-18808-Ljbffr BioSpace