Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures As a QA Validation Specialist, a typical day might include, but is not limited to, the following: Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria Analyzing the results of testing and determining the acceptability of results against predetermined 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 or outside contractors/vendors to complete validation tasks Providing mentorship and training less experienced Specialists Leading projects and preparing status reports May be required to oversee contingent workers This role might be for you if you: Have the ability to maintain integrity and honesty at all times Have the ability to work independently or as part of a team Have the ability to communicate with transparency Can continuously drive to improve processes for improved performance Can demonstrate respectful behavior at all times Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint) Can gather and organizes information Can meet commitments on time Can follow directions; performs well-defined tasks Have 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.
For Specialist level you must have 3+ years relevant experience within Biopharma or Pharma.
May substitute relevant experience for education.
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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.