Manager, C&Q Document Preparation (Manufacturing Support)
Core
Prepare, coordinate, and deliver commissioning and qualification (C&Q) lifecycle documentation for engineering projects and GMP manufacturing systems.
Role type
Manager, C&Q Document Preparation
Builds
Inspection-ready documentation supporting commissioning, qualification, and operational readiness for biotechnology manufacturing systems.
Domain
Biotechnology manufacturing / GMP / Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
C&Q lifecycle documentation authoring, qualification protocols and reports, risk assessments, traceability matrices, test scripts, GMP compliance, document version control, cross-functional collaboration, project schedule tracking, technical review coordination
Preferred skills
Bioprocess equipment familiarity (bioreactors, chromatography, filtration, centrifuges), CIP/SIP systems, single-use technologies, hybrid manufacturing systems, startup/commissioning of capital projects, risk-based qualification methodologies, data integrity requirements
Technologies
GMP documentation standards, CoE procedures, approved templates
Responsibilities
Prepare and revise commissioning and qualification lifecycle documentation, Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, Coordinate technical review cycles and incorporate comments, Ensure documentation is accurate, complete, compliant, and inspection-ready, Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams, Track assigned deliverables and support execution against project schedules, Maintain document organization and version control, Support audit and inspection readiness activities
Seniority
Manager, hands-on IC with strategic coordination
