Job Description:
The CQV Engineer is responsible for ensuring the commissioning, qualification, and validation of equipment, systems, and processes in drug substance production align with regulatory standards.
Key Responsibilities:
* Commissioning: Develop and execute plans, perform start-up and troubleshooting activities, document all procedures.
* Qualification: Create and execute IQ/OQ/PQ protocols, analyze qualification data to ensure regulatory compliance.
* Validation: Develop protocols for processes and systems, conduct risk assessments to guarantee cGMP compliance.
* Documentation: Prepare and maintain accurate protocols, reports, and SOPs to ensure compliance.
* Project Management: Manage multiple projects, coordinate with cross-functional teams, provide regular status updates.
* Compliance and Quality: Ensure compliance with regulatory standards, participate in audits, implement CAPAs as needed.
Requirements:
* Education: Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
* Experience: CQV experience in the pharmaceutical/biotech industry, specifically 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 Qualifications:
* Project Management Certification (PMP)
* Electronic documentation systems
* Lean Six Sigma knowledge
Working Conditions:
Occasional travel, cleanroom environment, flexibility for project timelines required.