Assoiate Manufacturing MES Specialist

Regeneron Ireland; Limerick; On-site; EUR 37,000 - 75,000; Full time

Job summary

Regeneron Ireland is seeking an Associate Specialist to lead deployment and support of MES systems, including MBRs, GMBRs and equipment data, in Raheen/Limerick. You will chair reviews, drive design specs, and lead pre-execution testing to ensure compliance and timely MES delivery.

You will coordinate with area owners for readiness, support go-live activities, and monitor KPI data to drive consistency across the MES/MFG team.

Qualifications

• BS/BA/BEng in a technical discipline.
• Associate Specialist: 0-2 years experience.
• Experience in Life Sciences manufacturing advantageous.

Responsibilities

• Leading deployment and support of MES/MBR/GMBR and equipment data.
• Chairing review sessions of MES deliverables against plan.
• MES design spec reviews using MR/BS templates.
• Leading pre-PE executions and testing of MES records.
• Reviewing data for OPM recipes to support MES build.
• Coordinating plant testing, GDP and compliance.
• Coordinating change control, documentation readiness.
• Ensuring Process Area readiness for MES deployment.
• Sustaining deployed MES records and timely close-out.
• Leading go-live activities and hypercare on production floor.
• Supervising KPI data to aid MES/MFG teams.

Skills

MES experience

Problem solving

Analytical skills

Education

BS/BA/BEng in Technical Discipline

Tools

Werum PAS/X

Job description

Location

Raheen, Limerick

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

Regeneron is 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.

For jobs in Canada: this posting is for an existing position. Salary Range (annually) €37,000.00 - €75,400.00

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
• 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/.

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.

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.