Process Compliance Specialist-Manufacturing

Regeneron Pharmaceuticals, Inc.; Limerick; Híbrido; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Process Compliance Specialist to join Manufacturing.

You will apply cGMP expertise, resolve process issues, and support compliance and continuous improvement across production operations. The role emphasizes coaching manufacturing personnel, leading investigations, technology transfer, and cross‑functional collaboration with Process Science and Tech Transfer teams.

Formación

• BS/BA/BEng in Life Sciences or related field and 2 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience
• Sr Specialist: BS/BA/BEng in Life Sciences or related field and 5 years experience

Responsabilidades

• Providing technical expertise to troubleshoot and resolve manufacturing process issues both on and off the production floor
• Coaching and developing manufacturing personnel to strengthen technical knowledge, process understanding, and operational capability
• Supporting process improvements, CAPA implementation, and work system enhancements to drive performance and compliance
• Leading technology transfer, process startup activities, and cross-functional collaboration with Process Science and Technology Transfer teams
• Monitoring, analyzing, and presenting process trends, technical metrics, and operational data to support informed decision‑making
• Conducting investigations into process variances and ensuring adherence to cGMP, regulatory requirements, site procedures, and safety standards
• Overseeing validation activities, equipment ownership responsibilities, and the scheduling of non‑routine manufacturing operations
• Authoring, reviewing, and approving controlled documentation while representing Manufacturing during audits and driving continuous improvement initiatives

Descripción del empleo

Team: Industrial Operations & Product Supply

Process Compliance Specialist-Manufacturing

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Process Compliance Specialist o join our Manufacturingteam. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Limerick
• Days (Monday to Friday)

What you’ll do:

• Providing technical expertise to troubleshoot and resolve manufacturing process issues both on and off the production floor
• Coaching and developing manufacturing personnel t strengthen technical knowledge, process understanding, and operational capability
• Supporting process improvements, CAPA implementation, and work system enhancements to drive performance and compliance
• Leading technology transfer, process startup activities, and cross-functional collaboration with Process Science and Technology Transfer teams
• Monitoring, analyzing, and presenting process trends, technical metrics, and operational data to support informed decision‑making
• Conducting investigations into process variances and ensuring adherence to cGMP, regulatory requirements, site procedures, and safety standards
• Overseeing validation activities, equipment ownership responsibilities, and the scheduling of non‑routine manufacturing operations
• Authoring, reviewing, and approving controlled documentation while representing Manufacturing during audits and driving continuous improvement initiatives

The environment and physical rhythms of this role:

• Collaborating effectively across functions to achieve shared business objectives
• Demonstrate technical problem‑solving capability
• Ability to prioritise and balance multiple tasks simultaneously

Let’s find out if we’re a fit:

• BS/BA/BEng in Life Sciences or related field and 2 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience
• Sr Specialist: BS/BA/BEng in Life Sciences or related field and 5 years experience

Thrive today. Grow tomorrow.

#LI-Onsite #JOBSIEST #REGNIELSM #IRELIM

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/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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)

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We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two‑way conversation, not a one‑way interview.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

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3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

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