Job Description

Within the Planning and Manufacturing Systems (PAMS) organization, the PAMS Project Manager will design, configure, validate, and support electronic batch records (EBRs) and manufacturing execution workflows using PAS-X and a new EBR system which is still in development, enabling compliant, efficient, and data-driven operations across GMP manufacturing. Based in the Bioprocess and Clinical Manufacturing Technology Department within the Biologics Pilot Plant (BPP) in West Point, PA, the Project Manager will own project planning, delivery and sustainment for MES/EBR (Manufacturing Execution System/Electronic Batch Record) initiatives. This role requires intense collaboration with Quality (QA/QC) and will serve as the primary interface between the BPP and the IT organization to ensure compliant, secure, and reliable system operations. The new EBR system will be deployed to support Clinical Bulk Manufacturing operations.

Key Responsibilities:

• Lead the design, configuration, and deployment of EBRs in PAS-X and the new EBR system (for Clinical Bulk Manufacturing), including master batch record development, parameters, phases, and workflows.

• Translate paper batch records/SOPs into structured EBR logic with clear user prompts, checks, and exception handling to ensure right-first-time execution.

• Author and help execute validation deliverables (URS, CS/DDS, IQ/OQ) consistent with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.

• Collaborate intensively with Quality (QA/QC) to define acceptance criteria, manage deviations and CAPAs, oversee change control, ensure audit readiness, and maintain robust electronic records/e-signatures.

• Serve as the primary interface between the BPP and IT for these EBR systems; coordinating infrastructure, security, access management, release/change processes, and support.

• Provide production support for MES/EBR applications, including incident management, root cause analysis, and corrective/preventive actions.

• Drive continuous improvement: streamline workflows, reduce manual steps, and optimize EBR design for usability, cycle time, error reduction and compliance.

• Train end users and superusers; develop SOPs, work instructions, and knowledge articles.

• Project management: develop charters, scope, schedules, resource plans, risk logs, and budgets; run stand-ups, track milestones, manage vendors, and communicate status to stakeholders.

• Participate in portfolio planning and contribute to MES standards, templates, and roadmap.

• Work with sub-team and use-case leads to track use-case metrics and rollup into program KPIs. Implement and manage any associated measurement methodologies (surveys, forms, etc).

• in partnership with workstream and sub-team leads, helps maintain resource planning data and escalates resource needs and changes.

• Proactively identifies and interrogates risks and develops appropriate mitigation strategies to ensure successful implementation of project plans. Escalates issues through the risk log and drives problem-solving and resolution within the team.

Cross-Functional Collaboration (IT & Automation):

• Partner closely with IT & Automation on infrastructure, hardware, networking, cybersecurity, and lifecycle management for MES/EBR system (server builds, VM provisioning, patching, backups, disaster recovery plans).

• Align with IT & Automation on identity and access management, single sign-on, role-based access controls, and change/release management.

• Coordinate with IT for database administration (SQL Server/Oracle), performance tuning, and high availability/DR strategies.

• Work with Automation teams on equipment and data integration into MES; interface with DeltaV, Ignition, PLCs, and instrument software.

Required Qualifications:

• BS or MS degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience (MES/EBR) within the Pharmaceutical or Biopharmaceutical industry.

• Deep, practical knowledge of PAS-X with a track record of delivering compliant, right-first-time EBRs; demonstrated, hands-on expertise in PAS-X, including advanced configuration and deployment.

• Proven ability to thrive in a fast-paced, dynamic environment with constantly shifting priorities and deadlines

• Excellent communication and collaboration skills across Quality, IT, Manufacturing, and Automation; ability to translate business needs into technical requirements and vice versa.

• Proven project management skills: planning, stakeholder management, risk/issue tracking, vendor coordination, and delivery in GMP environment. Hands-on PAS-X configuration experience: MBR design, phase logic, parameters, material management, recipe/version control, and release processes.

• Experience implementing and supporting EBR solutions within MES platforms (e.g., PAS-X or comparable systems), including workflow design, user guidance, checks, and exception handling.

• Strong understanding of EBR principles: data integrity (ALCOA+), electronic signatures, audit trails, exception handling, and right-first-time execution.

• Demonstrated partnership with IT on infrastructure, networking, cybersecurity, and database administration for validated systems.

• Familiarity with automation systems and OT protocols: PLCs (Rockwell/Siemens), DCS (DeltaV), SCADA, OPC UA, MQTT/Sparkplug, and historians.

• Familiarity with validation lifecycle and SDLC documentation (URS/CS/DS/IQ/OQ and risk-based testing).

Preferred Qualifications:

• Experience with PAS-X modules (e.g., PM, MM, WE, PI, BI) and ISA-88/ISA-95 standards.

• Background in biologics, aseptic processing, or continuous manufacturing; equipment interfacing (DeltaV, Rockwell, Siemens, Ignition).

• Exposure to serialization/track-and-trace and weigh & dispense systems.

• Knowledge of ERP (SAP PP-PI), LIMS, eQMS (e.g., TrackWise) integrations.

• Certifications: GAMP, PMP, and/or ISA/IEC 62443 cybersecurity.

• Experience integrating MES/EBR with shopfloor/enterprise systems (ERP, LIMS, historians, PLC/DCS/SCADA).

• Solid SQL skills and data modeling for manufacturing contexts; ability to query/cleanse production data.

Tools & Technologies:

• PAS-X (Werum), new EBR system (supporting Clinical Bulk Manufacturing), SQL Server/Oracle, OPC UA, Kepware or other OPC servers, REST/SOAP web services, historians (OSIsoft PI/AVEVA), Control Systems (DeltaV, Ignition, Unicorn, PLC, vendor custom), ERP/LIMS integration, project management tools (Jira, MS Project, Smartsheet), identity management (AD/Azure AD), virtualization (VMware/Hyper-V), and backup/DR tooling.

PRD

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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 salary range for this role is

$139,600.00 - $219,700.00

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.

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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

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Employee Status:

Regular

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Job Posting End Date:

01/19/2026

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