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Principal QA Validation Specialist - Equipment (Fill Finish)

Job Description

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The QA Validation department is hiring! The QA Validation Specialist validates and qualifies equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

  • Fill Finish Validation: this team will work multi-functional 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 helpful

  • Equipment Includes: Syringe and Vial Fillers, Lyophilizer, Semi-Automatic and Automatic Inspection, Assembly Machines, Packaging Machines, Serialization, Case Packer and Palletizer

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

  • Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.

  • Lead and drives projects and programs.

  • Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control)

  • Must be able to present in a “pressure test” scenario the technical area they are SME for

  • Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends.

  • Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

  • Reviews, edits and approves change controls, SOPs, reports and other documentation

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

  • Collaborates with functional departments to resolve issues.

  • Trains/advises less experienced Specialists.

  • May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.

  • Manage and drives projects and prepares status reports.

  • May present at both internal and external (regulatory) audits

  • Stays current with industry trends, regulatory requirement updates, and communicating same to team

  • May manage full time employees and/or contingent workers.

  • Performs other duties assigned by Management.

This role may be for you if you:

  • 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 aim to improve processes for improved performance

  • Demonstrate supportive behavior at all times

  • Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

  • Gathers and organizes information

  • Meets commitments on time

  • Performs well-defined tasks

  • 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 and the following years experience for each level:

  • Sr. QA Validation Specialist: 6+ years

  • Principal QA Validation Specialist: 8+ years

  • Staff QA Validation Specialist: 10+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$76,100.00 - $170,100.00