QA Validation Specialist

Working with the QA Validation team you will be responsible for validating systems and processes in accordance with regulatory requirements. Your role will involve supporting, following and implementing company manufacturing standards policies and procedures.

In this role, a typical day might include the following:

• Assessing and documenting Part 11/Annex 11 and data integrity controls

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

• Analyzing the results of testing and determines 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, change controls, SOPs, reports and corrective actions

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

• Managing projects and preparing status reports

This role may be for you if you:

• Have demonstrated knowledge of GxP, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), data integrity (ALCOA+)

• Are familiar with QC lab systems: LIMS (e.g., LabWare), CDS (e.g., Empower/OpenLab), ELN and data analytics systems

• Are comfortable working in a fast-paced setting

• Exhibit strong analytical and organisational skills

• Demonstrate proficiency in SQL/reporting basics, interface/integration testing, and familiarity with electronic validation management systems (eVMS) is advantageous

To be considered for this opportunity, you should have a BS/BA in Engineering, Chemistry, or Life Sciences with 2+ 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 culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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.