• Job Description

  Req#: R30614

  Validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

  As a Sr QA Validation Specialist, a typical day may include, but is not limited to, the following:

  • Generating, executing and/or reviewing master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

  • Leading all aspects of cleaning validation for program to ensure program adherence in accordance with approved schedules

  • Analyzing results of testing and determining the acceptability of results against pre-determined 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

  • Effectively communicate to key partners on cleaning validation programs (program adherence, success rate, issues / roadblock

  • Reviewing, editing and approving change controls, SOPs, reports and other documentation

  • Coordinating with other departments or outside contractors/vendors to complete validation tasks

  • Providing training and mentorship less experienced Specialists

  • Leading projects and prepares status reports.

  • May be required to supervise contingent workers.

  • Other duties assigned by management.

  Knowledge Skills & Abilities:

  • Ability to maintain integrity and honesty at all times

  • Ability to work independently or as part of a team

  • Ability to communicate with transparency

  • Continuously drive to improve processes for improved performance

  • Demonstrate supportive behavior at all times

  • Basic solid understanding of Microsoft Suite (Word, Excel, Powerpoint)

  • Captures and organizes information

  • Meets commitments on time

  • Effective time management skills

  • Seeks to identify continuous improvement needs

  To be considered for this position you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the field preferred; may substitute relevant experience for education.

  #IREADV #JOBSIEST #LI-Onsite #REGNIEQA

  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.S.-based 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.

• About the company

  Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York.

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