Process Compliance Specialist-Manufacturing

Regeneron Ireland; Limerick; On-site; EUR 37,000 - 88,000; Full time

Job summary

Regeneron Ireland is seeking a Manufacturing Specialist to troubleshoot production issues on and off the floor and develop the skills of the manufacturing team.

You will support process improvements, CAPA implementation, and cross‑functional collaboration to drive performance and compliance, while overseeing validation activities and preparing controlled documentation for audits.

Qualifications

• Minimum 2 years of cGMP manufacturing/engineering/scientific experience.
• BS/BA/BEng in Life Sciences or related field required.
• Experience with CAPA, investigations, and regulatory compliance is preferred.
• Strong problem-solving and analytical skills with attention to detail.

Responsibilities

• Provide technical expertise to troubleshoot and resolve manufacturing process issues.
• Coach and develop manufacturing personnel to strengthen technical knowledge.
• Support process improvements, CAPA implementation, and work system enhancements.
• Lead technology transfer and process startup activities with cross-functional teams.
• Monitor process trends and technical metrics to support decisions.
• Conduct investigations into process variances and ensure regulatory compliance.
• Oversee validation activities and documentation during audits.

Skills

Technical problem solving

Coaching & development

Process improvements

Cross-functional collaboration

Data analysis

Education

BS/BA/BEng in Life Sciences or related field

5 years experience for Sr Specialist

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

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

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

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

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.

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) €37,000.00 - €88,400.00

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. 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.

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.

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.