What are the responsibilities and job description for the CQV Engineer position at Katalyst CRO?
Responsibilities
- Prepare commissioning, qualification, and validation documents for equipment, utilities, and systems.
- Verify that systems and equipment operate according to design specifications and regulatory requirements.
- Prepare and maintain comprehensive validation documentation, including test protocols, reports, and standard operating procedures.
- Work closely with engineering, quality assurance, and production teams to resolve issues related to CQV.
- Implement corrective actions and improvements to maintain compliance with regulatory standards.
- Stay updated on industry regulations and standards related to CQV and ensure that all activities meet these requirements.
- Conduct training sessions on CQV procedures and best practices for employees.
- Participate in internal and external audits related to CQV activities.
- Bachelor's degree in engineering, life sciences, or a related field.
- Strong understanding of CQV protocols and regulatory requirements.
- Excellent problem-solving skills and attention to detail.
- Effective communication and teamwork abilities.
- Relevant experience in the pharmaceutical or biotechnology industry is preferred.
