Associate Manufacturing MES Specialist

Regeneron; Raheen Business Park; On-site; EUR 55,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Manufacturing MES Specialist to join the Manufacturing MES team in Ireland. The role focuses on deploying and supporting MES, managing Batch Records, and ensuring compliance with GMP across the production environment.

You will lead MES document reviews, coordinate with area owners for readiness, and drive go-live activities on the production floor, supporting continuous process improvements and data-driven decision making.

Qualifications

• BS/BA/BEng in a Technical Discipline required.
• Associate Specialist: 0-2 years experience.
• Experience working within a Life Sciences manufacturing environment advantageous.

Responsibilities

• Lead deployment and support of MES manufacturing Batch Records (MBR) and Equipment data.
• Chair review sessions of MES project deliverables against the project plan.
• Review MES design specs using MR/BS templates.
• Lead Pre-PE executions and testing of MES records.
• Review data for build of OPM recipes to support the MES build.
• Coordinate with plant testing and GDP/compliance for MES documents.

Skills

MES deployment

Werum PAS/X

GMP/compliance

Data analysis

Education

BS/BA/BEng in Technical Discipline

Job description

Team: Industrial Operations & Product Supply

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking an Associate Manufacturing MES Specialist to join our Manufacturing MES team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

What you’ll do:

• Leading deployment and support of the Manufacturing Execution Systems (MES) manufacturing Batch Records (MBR’s), Generic manufacturing Batch Records (GMBR’s) and Equipment data
• Chairing review and approval sessions of MES project deliverables against the overall project plan
• MES Design Spec review using the MR/BS and completed design spec/process flow map templates
• Leading Pre-PE executions (Static and Dynamic) and testing of MES records
• Reviewing data for build of OPM recipes to support the MES build
• Coordinating with the team on plant testing (Shakedowns) of MES documents, testing protocol and ensuring GDP and compliance
• Coordinating workflows for documentation approval, MES Deployment Support – documentation readiness and change control support
• Coordinating with area owners to ensure Process Area ready for MES Deployment (hardware, barcoding etc.)
• Coordinating sustaining deployed MES records to ensure timely close-out of executed MES records
• Leading MFG element of go live activities in the lead up to MES records live on the production floor and ensure hypercare activities
• Supervising KPI data to aid wider MES/MFG team in driving consistency and timeliness

The environment and physical rhythms of this role:

• Knowledge and experience of MES preferably Werum PAS/X
• Logical troubleshooting and problem-solving skills
• Excellent analytical, written and oral communication skills

Let’s find out if we’re a fit:

• BS/BA/BEng in a Technical Discipline required
• Associate Specialist: 0-2 years experience
• Experience working within a Life Sciences manufacturing environment advantageous

Thrive today. Grow tomorrow.

Does this sound like you? 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.

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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