CQV Engineer

Job description

Job Overview:

CQV Engineer, you will play a pivotal role in ensuring the successful commissioning, qualification, and validation of equipment and systems within biotechnology manufacturing facility. Your primary responsibilities will include developing and executing protocols, managing equipment documentation, and collaborating with cross-functional teams to ensure compliance with regulatory requirements and industry standards specific to the biotechnology sector.

Key Responsibilities:

• Develop, execute, and review qualification and validation protocols for bio-processing equipment, analytical instruments, and critical utility systems.
• Ensure that equipment meets predefined acceptance criteria and adheres to regulatory standards, including cGMP and ICH guidelines.

Commissioning and Start-Up:

• Collaborate with project teams during equipment installation and commissioning phases, ensuring proper installation and functionality.
• Conduct pre-functional and functional testing to verify equipment performance, including bioreactors, chromatography systems, and filtration units.

Documentation Management:

• Maintain comprehensive and well-organized equipment documentation, including equipment manuals, drawings, and specifications.
• Develop and manage validation master plans, traceable matrices, and associated documentation.

Risk Assessment and Mitigation:

• Perform risk assessments, including Hazard Analysis and Critical Control Points (HACCP) or Failure Modes and Effects Analysis (FMEA), to identify and mitigate potential risks associated with bioprocess equipment and systems.

Change Control and Deviation Management:

• Participate in the change control process to assess the impact of equipment changes on qualification and validation status.
• Investigate and resolve deviations and incidents related to equipment performance, ensuring timely resolution.

Regulatory Compliance:

• Stay current with biotech-specific regulations, guidelines, and standards and ensure strict compliance in all aspects of equipment qualification and validation.
• Support regulatory inspections and audits, providing documentation and expertise as needed.

Cross-Functional Collaboration:

• Collaborate closely with cross-functional teams, including Process Development, Quality Assurance, Manufacturing, and Facilities, to coordinate and execute CQV activities effectively.

Continuous Improvement:

• Identify opportunities for process improvement and efficiency enhancements within the biotech CQV process.
• Implement best practices and innovative solutions to improve equipment qualification and validation procedures.

Qualifications:

• Bachelor’s or higher degree in Engineering, Bioengineering, Biotechnology, or a related field.
• Relevant industry certifications (e.g., ASQ Certified Quality Engineer, ISPE Certified Pharmaceutical Industry Professional) preferred.
• Proven experience in equipment qualification and validation within the biotechnology or biopharmaceutical industry.
• Proficiency in regulatory requirements, including 21 CFR Part 210 and 211, and familiarity with ICH guidelines.
• Strong analytical and problem-solving skills with a keen attention to detail.
• Excellent communication and interpersonal skills to collaborate effectively with diverse teams.
• Proficiency in data management and documentation tools specific to bio-tech CQV.
• Knowledge of bioprocessing equipment and systems used in biotech manufacturing (e.g., bioreactors, chromatography systems, and filtration units).

This job specification provides a comprehensive outline of the core responsibilities and qualifications expected of an Engineer of this skillset. The specific duties and qualifications may vary depending on the organization and the complexity of processes and equipment involved.