Job Description
Within this role you will be responsible for providing technical leadership and mentorship 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. As a Sr QA Validation Specialist a typical day might include, but is not limited to, the following: Supervising the end-to-end qualification process ensuring each piece of equipment fits for the intended use that contribute to 365 inspection readiness program Following, fostering and implementing a quality culture and other company manufacturing standards, policies and procedures Previous experience as a SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits Scheduling, executing, reviewing and approving qualification activities Assessing executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements Reviewing, editing, and approving deviation notifications, deviation investigations and corrective actions Reviewing, editing, and approving change controls, SOPs, reports and other documentation Coordinating with other departments and outside contractors/vendors to complete validation tasks Collaborating with functional departments to resolve issues Managing and driving projects Preparing, reviewing and approving status reports Supervising, providing direction and assigning work to less experienced full-time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlines Staying current with industry trends, regulatory requirement updates and communicating the same to a team Travelling may be required This role might be for you if: You have expert knowledge of EU annex 11 and FDA 21 CFR Part 11 You have strong knowledge and understanding of the equipment used for QC analysis and operations If you have a strong background and are familiar with site change control, risk management and data integrity initiatives/programs You have strong knowledge of Data Integrity You have previous experience as a SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits You have the ability to prioritize and handle multiple tasks simultaneously You have project management experience To be considered for this opportunity you should have BS/BA in Engineering, Chemistry or Life Sciences with 5+ years of related experience within the field preferred; may substitute relevant experience for education. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.