Director, Engineering & Maintenance
hace 23 días
Rochester
Job Description • OverviewThe Director, Engineering & Maintenance is responsible for leading and overseeing all engineering, maintenance, and facility operations at the Rochester Site. This individual plays a critical role ensuring facility and equipment reliability, calibrations, regulatory compliance, and the safe, efficient, and uninterrupted production of radiopharmaceuticals. PRINCIPAL RESPONSIBILITIES: • Provide strategic and operational leadership to the engineering and maintenance functions at the Rochester, MN site., • Ensure the Rochester 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 capitol 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., • Assists in client onboarding and new product implementation between R&D and GMP facilities., • Drive innovation in building and equipment automation to support sterile and radioactive product handling., • Develop, manage, and monitor department budgets, KPI’s, and performance metrics., • Lead and mentor a multidisciplinary team of engineers, technicians, and maintenance personnel., • Performs 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 capitol 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 drug product development and manufacturing, for example: US FDA 21CFR part 211, EU GMP Annex 1, and WHO Annex 6, and 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., • Proven proficiency in Microsoft Office products, and familiarity with leading project management software tools and software., • Highly organized with strong attention to detail and commitment to high quality work, • Extended hours, shift and weekend work, and travel may be required from time to time., • Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling. THE FINE PRINT: The salary range for this position is $150,000 - $200,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location. Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members. This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”. Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
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