CQV Engineer
Oversees the commissioning, qualification, and validation of equipment, systems, and processes in drug substance production.
Responsibilities:
* Commissioning: Develops and executes plans, performs start-up and troubleshooting, documents activities.
* Qualification: Creates and executes IQ/OQ/PQ protocols, analyzes qualification data, ensures regulatory compliance.
* Validation: Develops protocols for processes and systems, conducts risk assessments, ensures cGMP compliance.
* Documentation: Prepares and maintains protocols, reports, and SOPs, ensuring accuracy and compliance.
* Project Management: Manages multiple projects, coordinates with teams, provides status updates.
* Compliance and Quality: Ensures compliance with regulatory standards, participates in audits, implements CAPAs.
Qualifications:
* Education: Bachelor's degree in Engineering, Life Sciences, or related field. Advanced degree preferred.
* Experience: CQV experience in pharmaceutical/biotech industry, with biopharmaceutical equipment (e.g., bioreactors, chromatography).
* Technical Skills: Knowledge of cGMP, regulatory requirements, and validation protocols. Experience with process and computer system validation.
* Soft Skills: Strong problem-solving, organizational, and communication skills. Ability to work independently and as part of a team.
* Preferred: Project Management Certification (PMP), electronic documentation systems, Lean Six Sigma knowledge.
* Working Conditions: Occasional travel, cleanroom environment, flexibility for project timelines.