C&Q Document Preparation Support (Drug Substance)
Core
Prepare, coordinate, and deliver commissioning and qualification (C&Q) lifecycle documentation for engineering projects and GMP manufacturing systems to ensure inspection readiness and regulatory compliance.
Role type
Senior Associate, C&Q Document Specialist (Drug Substance)
Builds
Compliant, inspection-ready documentation packages for commissioning, qualification, and operational readiness of biotechnology manufacturing systems.
Domain
Biotechnology / Pharmaceutical Manufacturing / GMP Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical writing and documentation excellence, GMP documentation practices, lifecycle validation approaches, risk-based qualification methodologies, document version control, cross-functional collaboration, project schedule tracking, audit and inspection readiness support.
Preferred skills
Bioprocess equipment familiarity (bioreactors, chromatography, filtration), CIP/SIP systems qualification, single-use technologies, startup/commissioning of capital projects, global pharmaceutical industry experience.
Technologies
GMP quality systems, approved C&Q templates, traceability matrices, test scripts, risk assessment tools.
Responsibilities
Author qualification protocols, reports, risk assessments, and traceability matrices; coordinate technical review cycles and incorporate revisions; partner with Engineering, Validation, Quality, and Manufacturing teams to gather technical information; track deliverables against project milestones; maintain document organization and version control; support audit and inspection readiness activities.
Seniority
Senior, hands-on IC
