Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
The MES Analyst will be responsible for working with internal customers and implementation teams to assist in the mapping of current and future state processes in manufacturing and apply the MES solution to these processes. Provides Configuration and support services to the Werum MES to meet end-user needs. Processes system change control, documents configuration, writes test plans and is responsible for user training.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Coordinates the needs of functional departments and establishes priorities for MES requirements gathering, system design and implementation.
- Works on complex MES recipe configurations to meet requirements of manufacturing and QA users.
- Responsible for MES documentation, including, converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans and summary reports.
- Design MES Recipe Authoring / Workflow / Electronic Batch Record solutions.
- Process MES change control requests.
- Review of company documentation including SOPs, SPECs, Batch Sheets and/or Manufacturing Records to assess MES impact.
- Works with Validation and Quality Assurance departments to ensure MES is implemented following development life cycle approach.
- Trains end-users and/or other MES trainers.
- Provides end-user support for the MES including troubleshooting problems at the application server level.
- Add, modifies, and removes users from the MES application.
Education and Experience:
- BS/BA in engineering, computer science, biological or physical science. Will substitute relevant industry experience for educational requirement.
- A minimum of 5 years of experience working with MES/EBRS or manufacturing systems within a life sciences manufacturing environment.
- No supervisory responsibilities are associated with this position.
Knowledge and Skills:
- Thorough knowledge of MES technologies, MES recipe configuration, MES workflow, SQL, Oracle and relational database concepts;
- MES system configuration experience;
- Knowledge of Werum PAS-X preferred, but experience with other MES software will be considered;
- Knowledge and experience in the integration of MES systems with ERP and Shop Floor Systems;
- Experience in programming automation systems (DCS), VB.Net and SQL preferred;
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The physical demands include those required of a normal office position. While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls, sit, talk, see, and hear. The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 10 pounds. The employee is occasionally required to crouch.
The work environment characteristics described here are representative of those an employee encounters while performing the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
There are no extreme conditions within this work environment. The noise level in the work environment is usually moderate
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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