Job Title: CQV Engineer

Location: Holly Springs, NC

long term contract on W2

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.