Job Title: CQV Engineer

Location: Holly Springs, NC(onsite)

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.