Technical Project Manager – CSV & Manufacturing Systems

We are seeking an experienced Technical Project Manager with strong expertise in Computer System Validation (CSV), quality compliance, and computerized manufacturing systems. The successful candidate will lead validation and compliance activities supporting manufacturing automation and digital transformation projects within a GMP-regulated pharmaceutical environment.

This role requires strong project governance, stakeholder management, risk oversight, and the ability to coordinate cross-functional teams across Business, Quality, Validation, Engineering, Automation, and IT.

Key Responsibilities

• Lead and coordinate CSV and compliance activities for computerized manufacturing system projects.
  
• Ensure project alignment with GxP requirements, internal SOPs, quality standards, and regulatory expectations.
  
• Provide governance and oversight throughout the validation lifecycle, including planning, documentation review, approval coordination, and compliance tracking.
  
• Manage project timelines, deliverables, dependencies, resources, risks, and compliance milestones.
  
• Coordinate validation, qualification, and quality activities across multiple technical and business stakeholders.
  
• Guide project teams on SDLC, Computer Software Assurance (CSA), risk-based validation, qualification, and change control.
  
• Facilitate risk assessments, issue resolution, deviation management, CAPA tracking, and change management activities.
  
• Act as the primary liaison between Business, Quality, Validation, Engineering, Automation, and IT teams.
  
• Identify delivery or compliance risks and drive appropriate mitigation and escalation.
  
• Provide regular project status, risk, and compliance updates to senior stakeholders and leadership.
  
• Ensure validation and qualification deliverables are completed, reviewed, approved, and maintained according to project schedules.
  

Requirements

• Strong experience as a Technical Project Manager within pharmaceutical manufacturing or another highly regulated environment.
  
• Demonstrated knowledge of Computer System Validation and GxP compliance.
  
• Experience managing projects involving computerized manufacturing, automation, laboratory, or production systems.
  
• Strong understanding of:
  • CSV and the validation lifecycle
    
  • Computer Software Assurance
    
  • Software Development Life Cycle
    
  • Risk-based validation
    
  • Qualification activities, including IQ/OQ/PQ
    
  • Change control and deviation management
    
  • CAPA and risk management
    
  • Data integrity and regulatory compliance
    
• Experience coordinating cross-functional teams across Quality, Validation, Engineering, IT, Automation, and Business functions.
  
• Strong project governance, stakeholder management, communication, and organizational skills.
  
• Ability to manage several workstreams, priorities, dependencies, and compliance milestones simultaneously.
  
• Experience reviewing, coordinating, and tracking validation and compliance documentation.
  

Relevant Technology Exposure

Experience supporting projects involving one or more of the following is highly desirable:

• DeltaV Distributed Control Systems
  
• PLC platforms, particularly Rockwell and/or Siemens
  
• Manufacturing process historians
  
• Laboratory automation systems
  
• Manufacturing Execution Systems
  
• Other GxP-regulated manufacturing automation or digital platforms
  

Preferred Qualifications

• Experience delivering capital, strategic, automation, or digital transformation projects.
  
• Familiarity with pharmaceutical regulatory expectations, including FDA and EMA requirements.
  
• Project management certification such as PMP, PRINCE2, or Agile certification is advantageous.
  
• Experience working with globally distributed teams and external implementation partners.
  

Benefits

• Location: USA – West Point, Pennsylvania
  
• Contract Type: Freelance / Contract
  
• Start date: September, 2026
  
• Time Allocation: 40 hours/week
  
• Pharmaceutical industry