Job DescriptionThe 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
QualificationsEducation- 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
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
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