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Scientific Search · 1 day ago

Director, Engineering and Maintenance

Rochester, MN

Full-time

Onsite

Director/Executive

8+ years exp

Scientific Search is seeking a Director of Engineering & Maintenance to oversee all engineering, maintenance, and facility operations. This role is critical in ensuring facility and equipment reliability, compliance, and the efficient production of products while leading cross-functional teams and implementing strategic plans.

Human ResourcesStaffing Agency

Growth Opportunities

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

Qualification

Engineering systemsCGMP complianceLeadership experienceProcess automationProject management softwareMechanical aptitudeInterpersonal skillsCommunication skillsCollaboration skillsAttention to detail

Required

Bachelor's degree in mechanical, electrical, nuclear, civil engineering or related field required

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

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