Project Management Institute
Associate Director, Planning and Manufacturing Systems Project Manager
Project Management Institute, Rahway, New Jersey, us, 07065
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 that 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 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 roll‑up into program KPIs; implement and manage any associated measurement methodologies (surveys, forms, etc). In partnership with workstream and sub‑team leads, help maintain resource planning data and escalates resource needs and changes. Proactively identify and interrogate risks, develop appropriate mitigation strategies, and drive 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.
Compensation & Benefits
The salary range for this role is $139,600.00 – $219,700.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance, retirement benefits, paid holidays, vacation, and compassionate and sick days.
Application Information
Apply through
https://jobs.merck.com/us/en
or via the Workday Jobs Hub (current employees). The application deadline is stated on the posting. See also our
Equal Employment Opportunity
statement and compliance requirements below.
Equal Employment Opportunity
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:
EEOC Know Your Rights
and
EEOC GINA Supplement . We are proud to be a company that embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills and backgrounds.
#J-18808-Ljbffr
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 that 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 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 roll‑up into program KPIs; implement and manage any associated measurement methodologies (surveys, forms, etc). In partnership with workstream and sub‑team leads, help maintain resource planning data and escalates resource needs and changes. Proactively identify and interrogate risks, develop appropriate mitigation strategies, and drive 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.
Compensation & Benefits
The salary range for this role is $139,600.00 – $219,700.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance, retirement benefits, paid holidays, vacation, and compassionate and sick days.
Application Information
Apply through
https://jobs.merck.com/us/en
or via the Workday Jobs Hub (current employees). The application deadline is stated on the posting. See also our
Equal Employment Opportunity
statement and compliance requirements below.
Equal Employment Opportunity
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:
EEOC Know Your Rights
and
EEOC GINA Supplement . We are proud to be a company that embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills and backgrounds.
#J-18808-Ljbffr