Facilities and Maintenance Operations Manager

2 weeks ago


Charleston, West Virginia, United States Alcami Corporation Full time

Position Overview:

The Facilities and Maintenance Operations Manager at Alcami Corporation is responsible for ensuring optimal performance in a dynamic environment by leading and supervising all initiatives related to the upkeep of the facility, operational equipment, and essential utilities. This role encompasses both routine operational support and specialized projects, which may include client-focused initiatives, site shutdowns, and enhancements or expansions of the facility.

On-Site Requirement:

This is a fully on-site role.

Key Responsibilities:

  • Provide strategic leadership and guidance to the Maintenance and Facilities teams.
  • Plan and oversee projects, including capital improvements and other significant undertakings.
  • Ensure compliance with Good Manufacturing Practices (GMP), including managing deviations, corrective actions, and compliance documentation.
  • Oversee maintenance programs, including preventative maintenance, repairs, and spare parts management.
  • Review and supervise the creation of maintenance work orders, offering troubleshooting and guidance as needed.
  • Manage critical utilities such as HVAC, compressed air, and water for injection (WFI).
  • Coordinate bi-annual facility shutdowns.
  • Oversee site security measures, including surveillance systems and access control.
  • Track and report key performance metrics to upper management.
  • Ensure timely completion of training and compliance with regulatory requirements.
  • Recruit, develop, and retain a high-performing team through effective coaching, mentoring, and performance management.
  • Directly supervise a team of 5-8 individuals.
  • Participate in the hiring process and make staffing decisions.
  • Schedule and evaluate the work of team members.
  • Conduct performance evaluations and recommend disciplinary actions when necessary.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree in Engineering or a related field is required.
  • A minimum of 6 years of relevant experience in a regulated environment is required; 8 to 10 years is preferred.
  • At least 3 years of supervisory experience is required.
  • Prior experience in the pharmaceutical industry is essential; experience with Contract Manufacturing Organizations (CMOs) or Contract Development and Manufacturing Organizations (CDMOs) is preferred.
  • Experience in aseptic processes is a plus.

Knowledge, Skills, and Abilities:

  • In-depth knowledge of pharmaceutical facility operations and maintenance.
  • Familiarity with FDA regulations and industry standards.
  • Strong written and verbal communication skills, along with effective coaching abilities.
  • Proficient in interpreting engineering designs and equipment specifications.
  • Strong negotiation skills and the ability to manage a multi-shift maintenance team.

Travel Requirements:

Occasional domestic travel may be required, up to 10%.

Physical Demands and Work Environment:

The physical demands of this position require the ability to communicate effectively, stand, walk, and sit for extended periods. The role may involve lifting up to 50 pounds and working in various environmental conditions.



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