Specialist MBR Author

Job Description

Specialist MBR Author

The Opportunity

• Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
• Be part of an organization driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
• Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company’s IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.

A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers.

Job Responsibilities

The Manufacturing Execution System (MES) Specialist acts as a subject matter expert for authoring and updating electronic master batch records. 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 MES Specialist will also be responsible for updating the Master batch records for MES integrations – DCS, SAP, LIMS etc. The specialist will be supporting MES trainings, collaboration, benefit realization, and standardization.  The Specialist will follow the standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes.

The MES 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.

Work directly with Manufacturing sites point of contacts to understand the requirements related to MBR/GMBRs and implements them following the SOPs and Life cycle procedures using electronic validation softwares like eVal (Kneat Validation Software).

Education Minimum Requirement:

• Bachelor’s Degree and 5+ years of MES support experience or 7+ 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 while working with Global stakeholders (North America, Europe & Singapore).

• Strong written and verbal communication skills Minimum five (5) 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) integration with PAS-X MES

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Required Skills:

Preferred Skills:

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Search Firm Representatives Please Read Carefully 
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. 

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