Categories: Pharmaceutical, Manufacturing, Quality Assurance, IT Systems

Job Description

Specialist MBR Author

 

The Specialist MBR Author acts as a subject matter expert. The primary responsibility is to ensure that the deployment of the Werum/Korber PAS-X electronic Master Batch Records are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits and are in line with site business process and technical standards. The Specialist is responsible for following standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes. The Specialist is responsible for activities that include the following:

 

• Identifies and implements continuous process improvement opportunities.

• Sustain electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Werum/Korber generic master batch record (GMBR) configuration. 

Executes the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance. Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing MES support to ongoing Electronic Batch Record (EBR) operations. Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their site Quality unit.

 

Education Minimum Requirement:

• Bachelor’s Degree and 4+ years of MES support experience or 6+ years of relevant MES experience

 

Required Experience and Skills:

•  Direct experience with MES (PAS-X) with strong experience in MBR, GMBR design

• Proven track record of analytical skills, problem solving and attention to detail.

• High personal integrity, credibility, and energy

 • Excellent communication and influencing skills.

• Strong written and verbal communication skills Minimum three (3) years of experience in a production regulated industry.   

• Strong understanding of manufacturing principles/processes (preferably Biologics) and ability to translate manufacturing requirements into Automation/Digital Solution

 

Preferred Experience and Skills:

Knowledge of SAP

Knowledge of L2 Systems (Historian, SCADA, DCS)

Required Skills:

Audit Management, Business Process Improvements, Data Management, Problem Management, Quality Management, Real-Time Programming, Software Development Life Cycle (SDLC)

Preferred Skills:

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Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/15/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.