Associate Director, Digital Systems Deployment Lead

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

Auditing Vaccines Operations Automation Governance Innovation Compassion Scalability Supply Chain Adaptability Systems Design Change Agility Pharmaceuticals Self-Motivation Quality Control Process Control Lean Principles Digital Systems Small Molecules Customer Service Business Process SAP Applications Telephone Skills Biopharmaceutics Biopharmaceuticals Influencing Skills Workday (Software) Personal Integrity Strategic Thinking Talent Development Business Continuity Process Development Process Engineering Contingent Workforce Process Optimization Chemical Engineering Regulatory Compliance System Implementation Industrial Engineering New Product Development Manufacturing Processes Relationship Management Pharmaceutical Sciences Functional Dependencies Manufacturing Operations Computer System Validation Verbal Communication Skills Data-Driven Decision Making Enterprise Resource Planning Good Manufacturing Practices Influencing Without Authority Continuous Improvement Process Systems Development Life Cycle, * BS or MS in Engineering, Pharmaceutical Sciences, Business, or related field, * ~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, 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}

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.

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The salary range for this role is $142,400.00 - $224,100.00

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., 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., Aerotek Randolph, NJ*On-Site Planning Plumbing Cast Iron Construction Health Advocacy Plumbing Systems Technical Supervision Artificial Intelligence Discounts And Allowances Critical Illness Insurance Employee Assistance Programs Construction Management Software +0 Account Executive Aston Carter New York, NY*Remote Sales Finance Planning Accounting Salesforce Procurement Supply Chain Communication Microsoft Excel Data Management Sales Pipelines Customer Service Spanish Language Mandarin Chinese Sales Prospecting Account Management Talent Recruitment Employee Onboarding Economic Development Relationship Building Organizational Skills Artificial Intelligence Critical Illness Insurance Customer Relationship Management +0 ADE - Bronx Aston Carter Bronx, NY*Remote Sales Finance Planning Accounting Salesforce Procurement Supply Chain Communication Customer Service Spanish Language Mandarin Chinese Account Management Economic Development Artificial Intelligence Critical Illness Insurance Customer Relationship Management +0