Associate Director, Planning and Manufacturing Systems Project Manager

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 E  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/E  (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 E  system will be deployed to support Clinical Bulk Manufacturing operations.

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

• Translate paper batch records/SOPs into structured E  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 E  systems; coordinating infrastructure, security, access management, release/change processes, and support.

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

• Drive continuous improvement: streamline workflows, reduce manual steps, and optimize E  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, helpers maintain resource planning data and escalates resource needs and changes.

• Proactively identify and interrogate risks and develop 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.

• Partner closely with IT & Automation on infrastructure, hardware, networking, cybersecurity, and lifecycle management for MES/E  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 Delta
  
  V, Ignition, PLCs, and instrument software.

• BS or MS degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience (MES/E ) 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: M  design, phase logic, parameters, material management, recipe/version control, and release processes.

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

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