Lead CQV Engineer (relocation to Europe: Copenhagen, Denmark)

This opportunity requires long-term relocation to the Copenhagen area in Denmark.

Consultys provides work visa sponsorship for this position.

Job Summary

Join our team as a Lead CQV Engineer and contribute to the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities. As a key member of our team, you will lead the generation of test packages, oversee the coordination and execution of commissioning and qualification processes, and provide valuable operational expertise to ensure project success.

Responsibilities:

• Lead the generation, review, and approval of commissioning and qualification test packages and related documents.
• Coordinate and execute commissioning and qualification activities, ensuring compliance with industry standards and project objectives.
• Provide technical expertise and guidance during the commissioning and qualification phase.
• Develop and implement comprehensive test plans for qualification, collaborating closely with the QA team.
• Report the status of assigned work to project stakeholders, providing updates on progress and challenges.
• Identify and address risks, issues, and optimization opportunities during the commissioning and qualification process.
• Support and mentor junior team members, enhancing their professional development.
• Engage in project management activities, such as resource planning, budget management, and stakeholder coordination.

Requirements:

• Minimum 4 years of experience in a leading role in the commissioning and qualification of equipment in new pharmaceutical/biotech manufacturing facilities
• Hands-on process engineering and/or operational experience
• Good GMP skills for completing qualification documentation
• Prior knowledge of working on plants operated with an MES is preferable.
• Experience in plant planning, and project management with a focus on plant automation or projects in technical computer science
• Fluent in English