Senior CSA CTOP Coordinator Onsite

Onite

2 Virtual Interviews

Contract Length: 2+ Years

8+ years CTOP experience, some pharma required

Specific to CSA scope

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 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