QA Validation Specialist - Cleaning

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: November 22, 2021

Job Description:

The QA Validation Department at Regeneron is adding to their team! We are currently looking to fill several QA Validation Specialists in areas including

• Lab Equipment Validation: this team focuses on the equipment used to create our product and supports our manufacturing areas; a background in downstream manufacturing is preferred
• Transport Qualification Validation: this team works closely with our Drug Manufacturing and Packaging Engineers to make sure our products are handled securely and not affected in transportation; a background in thermal dynamics 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
• Cleaning Validation: this team focuses on the clean-in-place and steam-in-place validation for the drug substance manufacturing areas; knowledge using in thermal validation systems (Kaye Validators) is preferredEach of these areas validate and qualify equipment, systems, 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 documentationThis 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 performanceTo 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
      • May substitute proven experience for education requirementDoes 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 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 maternity 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.#REGNQA

Keywords: Regeneron Pharmaceuticals, Inc., Troy , QA Validation Specialist - Cleaning, Other , Troy, New York