Job Title: CQV Engineer (W2 role only)
Location: Holly Springs, NC
6 month project to start, with likely extension to 12-18 months total duration.
About the Role:
We are seeking a skilled CQV (Commissioning, Qualification, and Validation) Engineer to join our team for the commissioning of our second expansion project, focusing on bioreactors. This is a critical role that will support our efforts to ensure that all systems and processes are fully operational and compliant with industry standards.
Key Responsibilities:
* Lead and execute commissioning, qualification, and validation activities for new pieces of equipment
* Develop and implement CQV protocols and reports.
* Collaborate with cross-functional teams to ensure project timelines and objectives 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 highly desirable.
* Strong understanding of regulatory requirements and industry standards.
* Excellent problem-solving and communication skills.
* Lead and execute commissioning, qualification, and validation activities for new pieces of equipment
* Develop and implement CQV protocols and reports.
* Collaborate with cross-functional teams to ensure project timelines and objectives 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 highly desirable.
* Strong understanding of regulatory requirements and industry standards.