Associate QA Validation Specialist

Regeneron Pharmaceuticals, Inc.; City of Troy (NY); On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a qualified professional to validate equipment, systems, and processes in a regulated environment. The role focuses on qualifying and reviewing protocols, analyzing data, and supporting manufacturing standards.

The candidate will collaborate with multiple teams, manage projects, and mentor junior specialists. Experience is valued in a cleanroom or GMP setting with strong documentation skills and the ability to implement improvements.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience.
• Must be able to work in a regulated environment and follow SOPs.

Responsibilities

• Generates, executes and reviews qualification and validation protocols and summaries.
• Analyzes testing results and determines acceptability.
• Investigates and troubleshoots problems and suggests improvements.
• Reviews deviation notifications and change controls.
• Coordinates with other departments and vendors to complete tasks.
• Trains and advises less experienced Specialists.
• Manages projects and prepares status reports.
• May oversee contingent workers.

Skills

Integrity and honesty

Independence or teamwork

Transparent communication

Process improvement

Respectful behavior

Time management

Information gathering

Commitment to deadlines

Following directions

Continuous improvement

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

Microsoft Office

Job description

Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

Essential Duties and Responsibilities

• Generates, executes 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, 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.
• Trains/advises less experienced Specialists.
• Manages projects and prepares status reports.
• May be required to oversee contingent workers.
• Other duties assigned by management.

Knowledge Skills & Abilities

• 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 respectful behavior at all times
• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
• Gathers and organizes information
• Meets commitments on time
• Follows directions; performs well-defined tasks
• Effective time management skills
• Seeks to identify continuous improvement needs

Education And Experience

• BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience within the field preferred; may substitute relevant experience for education.

We are committed to building a workplace with an inclusive culture. 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/.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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

Salary Range (annually)

$62,355.00 - $92,400.00