Job Title: CQV Engineer

Location: Holly Springs, NC

Duration: On-site in Holly Springs, NC. 6-month project to start, with a likely extension to 12-18 months total duration.

**Only W2/1099 - No C2C**

About the Role:

We are seeking a skilled CQV (Commissioning, Qualification, and Validation) Engineer to join our client team for the commissioning of our second expansion project, focusing on bioreactors. This critical role supports efforts to ensure that all systems and processes are fully operational and compliant with industry standards, including aseptic processing requirements.

Key Responsibilities:

• Lead and execute commissioning, qualification, and validation activities for new equipment, ensuring alignment with aseptic process requirements.
• Develop and implement CQV protocols and reports, addressing the needs of sterile environments such as bioreactors, autoclaves, refrigerators, and incubators.
• Collaborate with cross-functional teams to validate aseptic environments and maintain sterile conditions throughout operations.
• Troubleshoot and resolve challenges in maintaining aseptic conditions during the CQV process.
• Ensure compliance with regulatory requirements and industry standards related to aseptic processing.
• Provide technical expertise and guidance to the project team, with a focus on contamination control and sterility assurance.

Qualifications:

• Proven experience in commissioning, qualification, and validation activities, particularly with equipment used in aseptic processes such as bioreactors, autoclaves, refrigerators, and incubators.
• Familiarity with aseptic processing and Advanced Process Solutions (APS) for filling processes is highly desirable.
• Strong understanding of regulatory requirements and industry standards for aseptic environments, including GMP, FDA, and EU Annex 1 guidelines.
• Demonstrated expertise in contamination control strategies and best practices in sterile manufacturing.
• Excellent problem-solving and communication skills.