Job Title: CQV Engineer
Location: Holly Springs, NC
Key Responsibilities:
- Lead commissioning, qualification, and validation (CQV) activities for new equipment, including bioreactors, autoclaves, refrigerators, and incubators.
- Develop, execute, and review CQV protocols and reports.
- Collaborate with cross-functional teams to meet project timelines and objectives.
- Troubleshoot and resolve issues during the CQV process to maintain project progress.
- Ensure strict adherence to regulatory requirements and industry standards.
- Provide technical guidance and expertise to support the project team.
Qualifications:
- Demonstrated experience in CQV activities, especially with bioreactors and other equipment such as autoclaves, refrigerators, and incubators.
- Knowledge of APS (Advanced Process Solutions) for filling processes is a strong advantage.
- Solid understanding of regulatory compliance and industry standards.
- Strong problem-solving abilities and excellent communication skills.