Within this role you will be responsible for leading the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data.
This is an extended days position.
As a Manufacturing MES Specialist a typical shift might include, but is not limited to, the following:
Chair reviewing and approving sessions of MES project deliverables against the overall project plan
MES Design Spec reviewing using the MR/BS and completed design spec/process flow map templates
Populating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs)
Leading Pre-PE executions (Static and Dynamic) and testing of MES records
Coordinating team on plant testing (Shakedowns) of MES documents with MFG SME
Coordinating team and documentation of all testing protocol and ensure GDP and compliance
Coordinating of Workflows for documentation approval
Reviewing of data for build of OPM recipes to support the MES build
Coordinating of MES Deployment Support – documentation readiness and change control support
Coordinating with area owners to ensure Process Area readiness for MES Deployment (hardware, barcoding etc.)
Coordinating of sustaining deployed MES records to ensure timely close-out of executed MES records
Leading MFG element of launch activities in the lead up to MES records live on the production floor
Leading coordination of hypercare activities as part of wider MES team live on the production floor
This role might be for you if:
You demonstrate knowledge and experience of MES preferably Werum PAS/X
You possess logical troubleshooting and problem-solving skills
You have excellent analytical, written and oral communication skills
You demonstrate an ability to work within a successful team
To be considered for this opportunity you should have a BS/BA/BEng in a technical discipline, with 0-2 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience.
#REGNIELSM #LI-Onsite #IRELIM #JOBSIEST #REGNIEEC
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
We Are Working
ServerGuy
Coderwan
