C&Q Document Preparation Support (Finished Drug Product)
Core
Prepare, coordinate, and deliver commissioning and qualification lifecycle documentation for engineering projects and GMP manufacturing systems, specifically supporting finished drug product and packaging operations.
Role type
Senior Associate, Commissioning & Qualification (C&Q) Documentation Specialist
Builds
Inspection-ready documentation for commissioning, qualification, and operational readiness of engineering systems and manufacturing lines
Domain
Biopharmaceutical manufacturing, GMP compliance, packaging systems, and engineering validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP documentation practices, lifecycle validation approaches, risk-based qualification methodologies, technical writing, document version control, cross-functional collaboration, project schedule tracking
Preferred skills
Packaging equipment familiarity (labeling, cartoning, serialization), commercial manufacturing startup experience, integrated packaging systems knowledge, automated material handling systems
Technologies
GMP quality systems, risk assessment tools, traceability matrices, test scripts
Responsibilities
Author qualification protocols, reports, risk assessments, and traceability matrices; coordinate technical review cycles; ensure documentation accuracy and compliance; partner with Engineering, Validation, Quality, and Manufacturing teams; track deliverables against project milestones; support audit and inspection readiness activities
Seniority
Senior, hands-on IC