Senior Quality Assurance Validation Specialist (Oversight)

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 67,000 - 129,000; Full time

Benefits offered by this job

Student loan paydown program

Tuition reimbursement

Family care benefits

Relocation assistance

Well-being programs

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, New York is seeking a Sr. QA Validation Specialist to join the Quality Assurance team.

You will support validation of equipment, utilities, software, cleaning and sterilization processes in accordance with regulatory requirements, contributing to a fast-growing, science-driven organization. Requires a BS in life sciences or related field; 4+ years of QA validation experience for the Specialist role and 6+ years for the Senior level.

Qualifications

• Requires B.S in life sciences or related field.
• 4+ years of QA validation experience for the Specialist role; 6+ years for Sr. level.

Responsibilities

• Generates, executes and/or reviews qualification and validation protocols, summaries and data.
• Analyzes results and determines acceptability against criteria.
• Investigates validation issues and proposes solutions or improvements.
• Coordinates with departments or vendors to complete validation tasks.
• Prepares status reports and presents project updates to senior management.

Skills

QA validation

Regulatory compliance

Equipment validation

Education

B.S in life sciences or related field

Job description

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Sr. QA Validation Specialist, you will support validation of equipment, utilities, software, cleaning and sterilization processes at our facility in accordance with regulatory requirements by implementing company manufacturing standard policies and procedures. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where: Location: Rensselaer, New York, United States Monday-Friday, 8am‑4:30pm

What you’ll do:

• 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
• Investigation and troubleshooting problems which occur during validations and determines solutions or recommendation for changes and/or improvements
• Coordinates with functional department to resolve issues from validations
• Reviews, edits and approves deviation notifications, deviation investigations and corrective actions
• Coordinates with other departments or outside contractors/vendors to complete validation tasks
• Develop tracking mechanism of validation activity completion for various projects and prepare status report
• Present validation project and program status reports to senior management on a routine basis
• Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing
• Stays current with industry trends, regulatory requirement updates and communicating to teams
• May present at both internal and external (regulatory) audits

Let’s find out if we’re a fit:

Requires B.S in life sciences or related field; may substitute proven experience for education requirement QA Validation Specialist: 4 + years of experience Sr. QA Validation Specialist: 6+ years of experience Level will be determined based on experience.

Thrive today. Grow tomorrow.

Student loan paydown program & tuition reimbursement Family care benefits Relocation assistance Inclusion, culture and well‑being programs (including physical & mental health).

Eligibility and diversity

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.

Salary Range (annually) $67,400.00 - $128,700.00

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.

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.

About Regeneron

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.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

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.