Senior CSA CTOP Coordinator - Onsite

**** Webcam interview; *** Long term project ***Linkedin Must*** Onsite ****

Job Description:

Position Overview:

The Senior CSA CTOP Coordinator is responsible for managing Construction Turnover Packages (CTOPs) for CSA scopes on large-scale pharmaceutical capital projects. This role serves as the link between construction, quality, commissioning, and project controls to ensure CSA systems are completed, documented, and turned over in compliance with GMP, project sequencing, and validation readiness requirements. The ideal candidate has hands-on experience supporting CTOP execution on regulated life sciences projects and understands how CSA turnover directly impacts commissioning, qualification, and subsequent validation activities.

Key Responsibilities

• Lead the CSA Construction Turnover Package (CTOP) process from mechanical completion through turnover to Commissioning/Quality
• Develop, manage, and track CSA CTOPs in alignment with project turnover strategy and schedule milestones
• Coordinate with CSA construction teams to verify system boundaries, punch list closure, and mechanical completion readiness
• Work cross-functionally with Commissioning, CQV, QA, and Document Control to support timely and compliant system handover
• Review and validate CSA turnover documentation, including:
  • As-built drawings
  • Inspection and test records
  • Material traceability and certifications
  • Punch list and deficiency closeout documentation
• Maintain CTOP tracking logs and dashboards; provide regular status updates to project leadership
• Participate in turnover meetings, walkdowns, and system readiness reviews
• Ensure turnover packages meet GMP, FDA, and project-specific quality requirements
• Identify risks to turnover readiness and proactively drive resolution with construction and project teams
• Support audit readiness related to CSA construction and turnover documentation

Required Qualifications

• 8+ years CTOP experience, some pharma required - Specific to CSA scope
• 8+ years of experience in CSA construction, turnover, or project coordination roles within pharmaceutical, biotech, or regulated life sciences facilities
• Direct experience managing or supporting CTOPs for CSA scopes on large capital projects
• Strong understanding of:
  • CSA construction sequencing in GMP environments
  • Mechanical completion vs. system turnover requirements
  • How CSA readiness affects commissioning and qualification
• Experience working onsite with EPC/EPCM teams and multiple subcontractors
• Familiarity with GMP documentation standards and audit expectations
• Proficiency with CTOP tracking tools, project management systems, and document control platforms
• Excellent organizational, communication, and stakeholder coordination skills

Preferred Qualifications

• Experience on large greenfield pharmaceutical manufacturing projects
• Prior exposure to CQV interfaces for CSA systems (rooms, finishes, envelopes, etc.)
• Background working under EPCM delivery models