Associate QA Validation Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking an Associate QA Validation Specialist to validate and qualify equipment, systems, and processes in line with regulatory requirements and company manufacturing standards. This role supports the cleaning validation team with protocol generation, data review, and cross‑functional collaboration.

The position involves analyzing results, addressing deviations, coordinating with departments/vendors, and potential supervision of validation staff.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences.
• 0–2 years for Associate; 2+ years for Specialist; 5+ years for Senior Specialist.

Responsibilities

• Generates, implements and/or reviews qualification and validation protocols, reports and data.
• Analyzes testing results against criteria.
• Investigates problems and recommends changes.
• Reviews and approves deviation notifications, investigations, change controls, SOPs.
• Coordinates with other departments or external vendors to complete validation tasks.
• May supervise and assign work to staff and contractors.
• Manages projects and prepares status reports.
• May present at internal and external audits.
• Other duties as assigned.
• Some travel may be required.

Skills

Microsoft Office

Attention to detail

Time management

Communication

Teamwork

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

Microsoft Office

Job description

The Associate 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. This position is for the cleaning Validation team.

As an Associate QA Validation Specialist, a typical day might include the following:

• 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.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• Manages projects and prepares status reports.
• May present at both internal and external (regulatory) audits.
• Other duties assigned by management.
• Some travel may be required.

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 drive 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

In order to be considered for this position, you must hold a BS/BA 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 Specialist
• May substitute proven experience for education requirement

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

For other locations, additional information will be provided during the recruitment process.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $62,355.00 - $92,400.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.