What are the responsibilities and job description for the Validation Engineer position at Baanyan Software Services, Inc.?
Requirement
- 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.
Responsibilities
- Develop and execute CQV protocols: Prepare commissioning, qualification, and validation documents for equipment, utilities, and systems.
- Perform system inspections and tests: Verify that systems and equipment operate according to design specifications and regulatory requirements.
- Document CQV activities: Prepare and maintain comprehensive validation documentation, including test protocols, reports, and standard operating procedures.
- Coordinate with cross-functional teams: Work closely with engineering, quality assurance, and production teams to resolve issues related to CQV.
- Monitor system performance: Implement corrective actions and improvements to maintain compliance with regulatory standards.
- Ensure compliance: Stay updated on industry regulations and standards related to CQV and ensure that all activities meet these requirements.
- Train staff: Conduct training sessions on CQV procedures and best practices for employees.
- Support audits: Participate in internal and external audits related to CQV activities.
