C&Q Document Preparation Support (Finished Drug Product)
Core
Prepare, coordinate, and deliver commissioning and qualification (C&Q) lifecycle documentation for engineering projects and GMP manufacturing systems to ensure inspection readiness.
Role type
Senior Associate, C&Q Document Preparation
Builds
Compliant, inspection-ready documentation supporting commissioning, qualification, and operational readiness activities
Domain
Biopharmaceutical manufacturing / GMP / Engineering
Required skills
Technical writing, GMP documentation practices, risk-based qualification methodologies, lifecycle validation approaches, document version control, cross-functional collaboration, project tracking
Preferred skills
Packaging and finished drug product systems experience, packaging equipment familiarity (labeling, cartoning, serialization), commercial manufacturing startup experience, integrated packaging systems knowledge
Technologies
GMP systems, validation tools, document management systems
Responsibilities
Author qualification protocols, reports, risk assessments, traceability matrices, and test scripts; Coordinate technical review cycles; Partner with Engineering, Validation, Quality, and Manufacturing teams; Support audit and inspection readiness activities; Contribute to continuous improvement initiatives
Seniority
Senior, hands-on IC