The QA Validation Department at Regeneron is adding to their team! We are currently looking to fill several QA Validation Specialists in areas including
- Oversight Validation: this team oversees all documentation for all validation areas across the business, including QC, tech transfers and transfer of products; a background in pharmaceuticals is preferred
- Fill Finish Validation: this team will work cross functionally with all areas of the business to support our newly constructed Fill Finish facility; a background in equipment validation, project/process engineering and/or Facility Commissioning is preferred
- Equipment/Cold Chain Validation: this team focuses on two main areas supporting the equipment used to create our product, our manufacturing areas and the Cold Chain equipment (Warehouse and Controlled Temperature Units) where drug products and substance, raw materials are stored; a background in thermal dynamics is preferred
Each of these areas validate, qualify and verify equipment, systems, documentation and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. The day to day of a QA Validation Specialist could include, but are not limited to, the following:
- Generating, implementing 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 deciding the acceptability of results against pre-determined criteria
- Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements
- Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation
This role might be for you if you:
- Have validation or engineering experience in the pharmaceutical industry or similar industries
- Can coordinate with other departments or outside contractors/vendors to complete validation tasks
- Continuously seek to improve processes for improved performance
- Are looking for a great culture! Regeneron has best-in-class onsite and offsite events throughout the year, onsite cafeterias, company affiliated sports teams and clubs, and a culture centered on diversity and inclusion.
To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences and
- 0 – 2 years of relevant experience for an Associate
- 2+ years of relevant experience for a Specialist
- 5+ years of relevant experience for a Senior Specialist
- 8+ years of relevant experience for a Principal
- May substitute proven experience for education requirement
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.