Senior CSA CTOP Coordinator
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Job Location:
Lebanon, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
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
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
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
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
