Jobs at Regis University School for Professional Advancement (Now Hiring) — 80 open

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:

• Location: Raheen, Limerick

• Other information: 12/7 Shift Position

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

• Populating and reviewing MES documentation such as Config Spec (MESCS) and Trace Matrices (TM’s)

• 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.)

• Communicating task status to project meetings and escalating project impacting issues

• 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

• Monitoring KPI data to aid wider MES/MFG team in driving consistency and timeliness

The environment and physical rhythms of this role:

• Knowledge of BioPharma Manufacturing and Supply Chain Process

• Knowledge and experience of MES preferably Werum PAS/X

• In depth knowledge of concepts of GMP, ICH guidelines and GAMP requirements

• 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

• Specialist: 2+ years experience

• Experience working within a Life Sciences manufacturing environment advantageous

Thrive today. Grow tomorrow.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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)

€37,000.00 - €75,400.00