Digital Systems Deployment Lead (Onsite)

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 the speed agility and rigor of our Companys pipeline products. It will do so through 1). Enabling robust formulation and process development with flexible physical and digital infrastructure; 2). Delivering compliant high quality clinical supplies; 3). Developing talent with a new operating model and promoting a growth mindset.

The FLEx organization is seeking a highly motivated individual to serve as an Associate Director Digital Systems Deployment Lead. This role is responsible for leading the end-to-end deployment integration and sustainment of core digital manufacturing capabilities at the FLEx Center including the Manufacturing Execution System (MES) and SAP S/4 HANA as part of the global COMET program.

The successful candidate will be responsible for the SAP S/4 HANA transformation ensuring readiness alignment and successful deployment across FLEx business parallel the successful candidate will also act as a senior subject matter expert and MES technical lead ensuring MES capabilities (e.g. Electronic Batch Records Electronic Logs and Weigh & Dispense) are designed implemented and sustained in alignment with FLEx operating model principles across all modalities. By ensuring seamless integration between enterprise systems and FLEx manufacturing operations this position plays a critical role in enabling a scalable compliant and future-state digital manufacturing ecosystem at FLEx.

This position is an onsite role based in New Jersey and reports to the Systems Process Lead Director in the FLEx organization within Pharmaceutical Operations and Clinical Supply.

Primary Responsibilities

• Lead SAP S/4 HANA Deployment (COMET Program)
  • Serve as the FLEx site lead for SAP S/4 HANA deployment as part of the global COMET program
  • Own site readiness across impacted business areas including manufacturing supply chain quality and supporting functions
  • Partner with Global COMET teams to influence system design and ensure alignment with FLEx operating model and manufacturing processes
  • Drive business process harmonization and ensure end-to-end process integrity across SAP S/4 HANA and site operations
  • Coordinate site activities related to data readiness process changes testing training and deployment execution
  • Lead issue resolution and stabilization efforts during and post-deployment to ensure business continuity and operational success
• Lead MES Strategy & Execution
  • Lead the deployment and expansion of MES capabilities (EBR E-Logs Weigh & Dispense) across the FLEx Center
  • Drive design decisions to ensure alignment with site business processes global standards and operating models across modalities
• Own EBR Lifecycle & Standards
  • Oversee the end-to-end lifecycle of EBRs (design build testing deployment sustainment) to ensure compliance scalability and business value
  • Establish and enforce standards for EBR design authoring and optimization
• Drive Integration & Technical Architecture
  • Oversee MES integration with SAP (including alignment with S/4 HANA architecture) Level 2 systems and data flows between systems
  • Partner with IT and automation teams to ensure robust compliant system architecture
• Cross-Functional Leadership
  • Serve as the MES SME and primary point of contact for stakeholders across Operations Process Engineering Quality and IT
  • Act as FLEx representative for SAP S/4 HANA (COMET) and MES topics ensuring site needs are represented in global design and decision-making
  • Drive alignment across Operations Supply Chain Quality Process Engineering and IT for successful adoption of new business processes
• Sustainment & Continuous Improvement
  • Ensure MES remains in a validated compliant state while continuously improving system performance and business processes
  • Apply lean principles to optimize EBR lifecycle processes and drive efficiency
• Program & Vendor Oversight
  • Provide governance of MES and S/4 HANA delivery including scope schedule and benefit realization
  • Manage scope timeline risks and cross-functional dependencies to ensure successful delivery of transformation programs
  • Lead and manage external partners/contractors to ensure adherence to standards and delivery expectations
• Training Adoption & Network Collaboration
  • Drive training strategy and user adoption for both SAP S/4 HANA and MES across site functions
  • Share best practices and harmonize approaches with other sites in the network
• Compliance & Inspection Readiness
  • Ensure adherence to cGMP SDLC and validation requirements
  • Support regulatory inspections and audits as required

Qualifications

Education

• BS or MS in Engineering Pharmaceutical Sciences Business or related field

Required Experience

• 8 years of experience in MES deployment and/or sustainment (preferably PAS-X or similar platforms)
• Demonstrated experience leading MES implementations or major workstreams
• Demonstrated experience leading or supporting large-scale ERP transformations (SAP S/4 HANA preferred) in a manufacturing or GMP environment
• Strong understanding of pharma manufacturing principles/processes and ability to translate manufacturing requirements into a Digital Solutions
• Strong expertise in EBR authoring optimization and lifecycle management
• Experience integrating MES with SAP and manufacturing systems (Level 2 or equivalent)
• Experience managing cross-functional business process changes beyond system implementation
• High personal integrity credibility and energy
• Strong written and verbal communication skills

Preferred

• Knowledge of SDLC computer systems validation (CSV) and regulatory expectations
• Demonstrated ability to influence standards and drive continuous improvement initiatives

#eligibleforERP

#PSCS
FLEx2026

Sterile2026

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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