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.
• Previous experience with companies like Novo Nordisk or Eli Lilly is a plus.
• Strong understanding of regulatory requirements and industry standards.
• Excellent problem-solving and communication skills.

Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.