Engineering Manager (CQV) - Up to €220k - Raleigh Area

Optimus Search
Raleigh, NC

CQV Engineering Manager – Hybrid (North Carolina)

Up to $225,000 Base Salary Fast‑Growing Biotech Company


About the Opportunity

An up‑and‑coming biotech company in North Carolina is searching for a CQV Engineering Manager to lead its commissioning, qualification, and validation function during a period of rapid expansion. This hybrid role offers the chance to shape validation strategy, build capability, and influence the future of a company on the rise.


What You’ll Lead

  • CQV Strategy & Leadership - Own the commissioning, qualification, and validation roadmap across new and existing systems.
  • Team Management - Lead, mentor, and develop a high‑performing CQV engineering team.
  • Facility & Equipment Qualification - Oversee qualification of utilities, cleanrooms, process equipment, and automation systems.
  • Regulatory Compliance - Ensure alignment with FDA, cGMP, and industry validation standards.
  • Project Execution - Drive CQV activities for capital projects, tech transfers, and new product introductions.
  • Continuous Improvement - Implement best practices to streamline validation lifecycle processes.


What Makes This Role Stand Out

  • Hybrid flexibility in the North Carolina area
  • Up to $225K compensation for the right experience
  • A chance to join a high‑growth biotech at a pivotal moment
  • Direct influence on CQV strategy, systems, and culture
  • High visibility with senior leadership and cross‑functional teams


Who You Are

  • Experienced CQV leader with a strong background in biotech, pharma, or advanced therapeutics
  • Skilled in managing teams, vendors, and complex validation programs
  • Confident navigating FDA, cGMP, and GAMP frameworks
  • Motivated by building, scaling, and improving systems in a growing environment


Please send your updated CV to [email protected] to be considered.

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