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Maintenance Manager

Leiters Inc

Englewood, COOnsitePosted 12 days ago$110,000 - $140,000/year
Full TimeSenior LevelManufacturing & CMCCDMO
Original posting ↗

Summary

The Maintenance Manager reports to the Vice President of Engineering and is responsible for all maintenance functions of physical plant, utilities and manufacturing equipment including aseptic filling and packaging. Responsible for planning, assigning, and directing a team of maintenance technicians. Supervise and plan all maintenance, repairs, equipment upgrades, and projects performed over multiple shifts. Review and approve all maintenance work orders for accuracy and compliance.

Job description

Essential Functions

  • Initiate and drive continuous improvement of maintenance methods and/or projects to reduce equipment downtime and reactive maintenance response.
  • Deploy strategies in reliability that build maintenance and technician capabilities.
  • Utilize visual factory concepts to improve and communicate asset utilization and plant performance.
  • Ensure proper utilization of Blue Mountain Computer Maintenance Management System (CMMS).
  • Develop and deploy 24/7 FMS alarm monitoring, response, and acknowledgement.
  • Communicate and collaborate cross-functionally to assist the F & E team in solving operational issues.
  • Ensure all company and site Engineering policies and procedures are adhered to.
  • Report appropriate project and work task status to the VP Engineering, project team members and project management personnel.
  • Lead biannual site facility shutdown coordinating all preventative maintenance and calibration activities.
  • Manage and resolve equipment and building technical issues or changes arising throughout the project life cycle while ensuring overall project objectives of scope, cost and schedule are adhered to.
  • Ensure all facilities, utilities and/or equipment are handed over effectively to end users.
  • Investigate and troubleshoot equipment failures and complete appropriate deviation and CAPA action items as assigned.
  • Examine monthly expenses and approve monthly cost forecasts.
  • Prepare annual expense budget for maintenance.
  • Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
  • Other duties as assigned.

Supervisory Responsibilities

  • Directly hire and lead a team of technicians.
  • Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
  • Conduct regular 1:1s to address performance, feedback and relationship building.
  • Identify training and development needs within the team and facilitate as able.

Experience and Necessary Competencies

  • Bachelor's degree in a relevant field and/or equivalent experience required.
  • 4+ years' experience in managing production and facilities maintenance for a cGMP or FDA regulated environment required. 8+ years preferred.
  • Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
  • Excellent personal coaching skills.
  • Strong results orientation.
  • Excellent matrix management skills and organizational skills.
  • Good understanding of ladder logic and its underlying principles.
  • Good troubleshooting and root cause analysis.
  • Proficient in Blue Mountain BMRAM CMMS preferred.
  • General understanding of pharma automation and utilities preferred.
  • Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines required.
  • Proficient written, verbal and oral English communication skills are required.
  • Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.

Physical Requirements

  • Ability to stand or sit for extended periods of time.
  • Ability to lift, push and pull up to 50 pounds periodically.
  • Ability to maintain a gowning qualification.
  • Ability to work off-shifts and/or weekends when required.

Requirements

  • Bachelor's degree in a relevant field and/or equivalent experience required
  • 4+ years' experience in managing production and facilities maintenance for a cGMP or FDA regulated environment required
  • 8+ years' experience preferred
  • Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred
  • Excellent personal coaching skills
  • Strong results orientation
  • Excellent matrix management skills and organizational skills
  • Good understanding of ladder logic and its underlying principles
  • Good troubleshooting and root cause analysis
  • Proficient in Blue Mountain BMRAM CMMS preferred
  • General understanding of pharma automation and utilities preferred
  • Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines required
  • Proficient written, verbal and oral English communication skills required
  • Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel

Benefits

  • Health Insurance
  • Flexible Spending Account
  • Health Savings Account
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • Employee Assistance Program
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • 401(k) Matching
  • Paid Time Off
  • Tuition Reimbursement
  • Referral Bonus
  • Annual Bonus

Company overview

Leiters Health, operating as Leiters Inc, is a leading FDA-registered 503B outsourcing provider specializing in high-quality compounded sterile preparations and pharmacy services. Founded in 1926 and headquartered in Englewood, Colorado, the company has evolved from a small family pharmacy into a sophisticated pharmaceutical manufacturing organization serving hospitals, surgery centers, clinics, and physician offices nationwide. Leiters operates state-of-the-art facilities that produce ready-to-administer compounded medications, including pre-filled IV bags, syringes, and concentrated vials for critical care, ophthalmology, anesthesia, and pain management applications. The company's expertise spans sterile pharmaceutical manufacturing, repackaging, and compounding, with a strong focus on quality, consistency, and regulatory compliance under Current Good Manufacturing Practices (cGMP). Leiters plays a vital role in addressing drug shortages and supporting healthcare providers with reliable, high-quality pharmaceutical solutions that enhance patient safety and streamline clinical workflows.

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