Director, Engineering and Maintenance

Director, Engineering & Maintenance

onsite in Rochester, MN

The Director, Engineering & Maintenance is responsible for leading and overseeing all engineering, maintenance, and facility operations. This individual plays a critical role in ensuring facility and equipment reliability, calibrations, regulatory compliance, and the safe, efficient, and uninterrupted production of products.

This role leads cross-functional teams including facilities engineering, utilities, automation, calibration, maintenance, and capital projects. The Director will develop strategic plans and implement best practices to support current operations and future expansions, ensuring alignment with business goals and regulatory expectations.

Principal Responsibilities

• Provide strategic and operational leadership to the engineering and maintenance functions at the site.
• Ensure the facility and its equipment are maintained in a validated, compliant, and operationally ready state in accordance with CGMP, radiation safety, and EH&S requirements.
• Assist in capital project execution, including facility upgrades, equipment installations, and technology improvements.
• Oversee preventative and corrective maintenance programs, asset lifecycle management, and reliability-centered maintenance strategies.
• Collaborate with Quality Assurance and Manufacturing/Operations to support audits, regulatory submissions, and continuous improvement initiatives.
• Assist in client onboarding and new product implementation between R&D and GMP facilities.
• Drive innovation in building and equipment automation to support sterile and specialized product handling.
• Develop, manage, and monitor department budgets, KPIs, and performance metrics.
• Lead and mentor a multidisciplinary team of engineers, technicians, and maintenance personnel.
• Perform other duties as assigned.
  
  

Qualifications & Responsibilities

• Bachelor’s degree in mechanical, electrical, nuclear, civil engineering or related field required; advanced degree preferred.
• Minimum of 8 years of progressive experience in pharmaceutical, radiopharmaceutical, or other regulated manufacturing environments.
• Minimum 5 years of leadership experience with direct oversight of technical teams and capital projects.
• Deep understanding of engineering systems, equipment reliability, and facility infrastructure in a CGMP environment.
• Knowledge of and ability to apply cGMP requirements to sterile injectable product development and manufacturing, for example: US FDA 21CFR part 211, EU GMP Annex 1, and WHO Annex 6, with ability to apply other regulatory requirements as needed (e.g., Radiation Safety).
• Demonstrated ability to lead cross-functional teams and manage complex projects to successful completion under strict timelines.
• Experience with process automation, digital solutions, and operational excellence methodologies preferred.
• Strong interpersonal, communication, and collaboration skills with the ability to influence across multiple levels of an organization.
• Proficiency in Microsoft Office products and familiarity with leading project management software tools.
• Highly organized with strong attention to detail and commitment to high-quality work.
• Extended hours, shift and weekend work, and occasional travel may be required.
• Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and handle frequent crawling, stooping, crouching, and kneeling.
  
  

If you would like to learn more about this fantastic opportunity, please reach out to Kiera@ScientificSearch.com