Senior CSA CTOP Coordinator Onsite
Listed on 2026-07-01
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Contract Length: 2+ Years
Job Title: Senior CSA CTOP Coordinator
Location: Lebanon, IN
Position OverviewThe 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
- 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 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
- 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
- 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
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