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 Company's 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 processes. In 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:

Adaptability, Adaptability, Biopharmaceutics, Business Processes, Change Agility, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Digital Manufacturing, Drug Product Development, Estimation and Planning, GMP Compliance, Manufacturing Processes, Manufacturing Quality Control, Pharmaceutical Process Development, Process Control Automation, Process Engineering, Process Optimization, Product Formulation, Regulatory Inspections, Safety Compliance, Stakeholder Relationship Management, Standards Compliance, Strategic Thinking, Talent Development {+ 2 more}

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 characteristics.As 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:

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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 another's 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

$142,400.00 - $224,100.00

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 employee's 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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/7/2026

*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.

Requisition ID:R402413

PDN-a202914b-237e-4e92-a5b8-fa24cb3f756f