The CQV Engineer will oversee the commissioning, qualification, and validation of equipment, systems, and processes in drug substance production. The role ensures systems comply with regulatory standards, working closely with cross-functional teams to ensure successful project delivery.
Responsibilities
- Commissioning: Develop and execute plans, perform start-up and troubleshooting, document activities.
- Qualification: Create and execute IQ/OQ/PQ protocols, analyze qualification data, ensure regulatory compliance.
- Validation: Develop protocols for processes and systems, conduct risk assessments, ensure cGMP compliance.
- Documentation: Prepare and maintain protocols, reports, and SOPs, ensuring accuracy and compliance.
- Project Management: Manage multiple projects, coordinate with teams, provide status updates.
- Compliance and Quality: Ensure compliance with regulatory standards, participate in audits, implement 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.
