Seeking an experienced Technical Project Manager with strong Computer System Validation (CSV) and compliance knowledge to lead validation and quality compliance activities for computerized manufacturing systems within a GMP-regulated pharmaceutical environment. The role requires effective project governance, stakeholder management, risk oversight, and coordination of cross-functional teams supporting manufacturing automation and digital transformation initiatives.

Key Responsibilities

• Lead and coordinate CSV and compliance activities for manufacturing system projects, ensuring alignment with GxP requirements, internal procedures, and regulatory expectations.
• Provide governance and oversight for validation lifecycle deliverables, including planning, review, approval coordination, and compliance tracking.
• Drive project execution across multiple stakeholders, ensuring timely delivery of compliance, validation, and qualification activities.
• Guide project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, change control, and compliance processes.
• Facilitate risk assessments, issue resolution, CAPA tracking, and change management activities.
• Act as the primary liaison between business, quality, validation, engineering, and IT teams to ensure successful project delivery.
• Monitor project timelines, dependencies, risks, and compliance milestones while providing regular status updates to leadership.Experience working with or supporting projects involving one or more of the following:
• DeltaV Distributed Control Systems (DCS)
• PLC Platforms (Rockwell and/or Siemens)
• Manufacturing Process Historians
• Laboratory Automation Systems
• Manufacturing Execution Systems (MES)

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