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Skills: Manufacturing Execution Systems, MES, Werum PAS/X, GMP, ICH guidelines
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$37k–$75k/yr
Full-time
bachelor degree
Annual bonuses, Incentive plans, Equity awards, Pension or retirement benefits, Health and wellness programs, Fitness centers
Posted 1d ago
~40 hrs/week
Responsibilities
The role involves leading the deployment and support of Manufacturing Execution Systems (MES) and managing project deliverables, including design specifications and documentation. You will coordinate plant testing, ensure compliance with GMP standards, and support go-live activities on the production floor.
Requirements
Candidates must hold a BS/BA/BEng in a technical discipline and possess experience within a Life Sciences manufacturing environment. Strong knowledge of MES, specifically Werum PAS/X, along with an understanding of GMP and GAMP requirements is essential.
Full job description
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 Specialistto join ourManufacturing 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.
Regis University School for Professional Advancement (SPA) offers a values-centered Jesuit education specifically designed for the adult learner.
Our students are working professionals, parents, and spouses seeking their Bachelor's, Master's, or certificate from an accredited University that respects the balance between work, school, and family.
We are proud of our reputation as a national leader in adult education, offering innovative online learning, multiple Colorado campus locations, nationally-recognized curriculum, and dedicated and award-winning faculty. Backed by over 130 years of tradition and academic excellence, Regis University SPA continues to make earning a respected degree accessible and affordable.
OUR JESUIT FOUNDATION AND VISION
Regis University is rooted in a 500-year-old Jesuit academic tradition called to educate the whole person--mind, body, and soul. Today, Regis University educates men and women to take leadership roles and to make a positive impact in a changing society.
OUR HISTORY
With over 130 years of academic rigor, intellectual exchange, and faculty commitment to each student's personal development, Regis University continues to excel as a top university in the West.
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How many Technology jobs are open in Limerick, Ireland right now?
There are currently 133 open technology positions in Limerick, Ireland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Technology roles in Limerick, Ireland?
Companies currently hiring include Analog Devices, Northern Trust Asset Management, Verizon, EY, AMCS Group, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Technology jobs in Limerick, Ireland?
Yes — 53 of the 133 open technology positions offer remote or hybrid work (1 remote, 52 hybrid).
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