Specialist, Manufacturing Execution System (MES)

Job Description

The FLEx Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The FLEx organization has a mission to enable development of our Company’s pipeline products with speed, agility, and rigor. This mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant, high quality clinical supplies; 3) Developing talents with a new operating model and promoting a growth mindset.

The FLEx organization is seeking a highly motivated individual to serve the role of Specialist, Manufacturing Execution System. The successful candidate will support the deployment and sustainment of a Manufacturing Execution System (MES) at the FLEx Center to enable Electronic Batch Records (EBR), Electronic Logs (E-Logs), and Weigh & Dispense functionality. The Specialist will help to ensure that the MES system functionality will maximize business benefits and meet operating model principles across all modalities at the FLEx Center in a compliant manner. The role is based in Rahway, New Jersey and reports to the Systems Process Lead Director at the FLEx Center in the Pharmaceutical Operations and Clinical Supply organization.

Responsibilities of the MES Specialist include but not limited to:

• Become an MES subject matter expert and apply knowledge of manufacturing processes to partner with Process Engineers, Formulators, Operations, and Quality resources, working together with them to design, develop, revise, and sustain Electronic Batch Records and all other MES functionality.

• Execute 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.

• Participates in the creation and execution of the site MES SOPs and training strategy and sustainment for end users of the MES system.

• Identify and implement continuous process improvement opportunities.

• Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing onsite support to ongoing MES system operations.

• Develop knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their respective Quality units.

• Gain an in-depth knowledge of MES integration with SAP and acquire sufficient expertise in SAP master data and transactions to effectively troubleshoot interface problems from both the MES and SAP perspectives.

• Coordinate and share best practices with other company sites in the network.

• Assist in external agency inspections, as needed.

Qualifications

Education Minimum Requirement:

• BS or MS degree in Engineering, Pharmaceutical Sciences, Business, or a related field

Required Experience and Skills:

• Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into an Automation/Digital Solution

• Minimum of 2 years of experience in a GMP manufacturing environment

• Ability to work collaboratively as part of a team across various functions in a challenging and changing global environment.

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

• High personal integrity, credibility, and energy

• Strong written and verbal communication skills

Preferred Experience and Skills:

• Experience in pharma/sterile manufacturing and Weigh & Dispense operations

• Direct experience with MES systems

• Experience with MES deployment and EBR authoring

• Familiarity with MES integration to SAP and Level 2 production systems

• Proficient in SAP ECC – BOM, Recipe, PV, Process Order execution, Material Handling

• Knowledge of SDLC and computer systems validation

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed 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. 

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