The CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances. This role ensures that all systems operate as intended and comply with regulatory standards. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.
Key Responsibilities:
1. Develop and execute commissioning plans for new and existing equipment and systems.
2. Perform equipment start-up and troubleshooting to ensure proper operation.
3. Document commissioning activities and results.
4. Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems.
5. Ensure that all qualification activities comply with regulatory requirements and industry standards.
6. Analyze qualification data and prepare comprehensive reports.
7. Develop and execute validation protocols for processes and computer systems.
8. Conduct risk assessments and gap analyses to identify critical process parameters and control strategies.
9. Ensure validation activities are aligned with current Good Manufacturing Practices (cGMP) and regulatory guidelines.
10. Prepare and maintain detailed documentation, including protocols, reports, and standard operating procedures (SOPs).
11. Ensure all documentation is accurate, complete, and compliant with regulatory requirements.
12. Manage multiple CQV projects simultaneously, ensuring timely completion and adherence to project timelines.
13. Coordinate with cross-functional teams to ensure seamless project execution.
14. Provide regular project updates and status reports to stakeholders.
15. Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM).
16. Participate in internal and external audits and inspections.
17. Implement corrective and preventive actions (CAPAs) as needed.
Qualifications:
Education:
1. Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
Experience:
1. Experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.
2. Experience with commissioning, qualification, and validation of biopharmaceutical equipment and systems (e.g., bioreactors, chromatography systems, filtration systems).
Technical Skills:
1. Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements.
2. Proficiency in developing and executing IQ/OQ/PQ protocols.
3. Familiarity with risk-based approaches to validation (e.g., ASTM E2500).
4. Experience with process validation and computer system validation.
Soft Skills:
1. Excellent problem-solving and analytical skills.
2. Strong project management and organizational skills.
3. Effective communication and interpersonal skills.
4. Ability to work independently and as part of a team.
Preferred Qualifications:
1. Certification in Project Management (PMP) or CQV-related certifications.
2. Experience with electronic documentation systems and validation lifecycle management software.
3. Knowledge of Lean Six Sigma methodologies.
Working Conditions:
1. This position may require occasional travel to other sites or manufacturing facilities.
2. Ability to work in a cleanroom environment and adhere to gowning requirements.
3. Flexibility to work outside of regular business hours as needed to support project timelines.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Quality Assurance, and Manufacturing
Industries
Architecture and Planning and Pharmaceutical Manufacturing
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