Job Title: CQV Engineer

Location: Holly Springs, NC

Key Responsibilities:

• Lead and execute commissioning, qualification, and validation activities for newpieces of equipment
• Develop and implement CQV protocols and reports.
• Collaborate with cross-functional teams to ensure project timelines andobjectives are met.
• Troubleshoot and resolve any issues that arise during the CQV process.
• Ensure compliance with all regulatory requirements and industry standards.
• Provide technical expertise and guidance to the project team.

Qualifications:

• Proven experience in CQV activities, particularly with bioreactors, autoclaves,refrigerators and incubators
• Experience with APS (Advanced Process Solutions) for filling processes is highlydesirable.
• Strong understanding of regulatory requirements and industry standards.
• Excellent problem-solving and communication skills.