A Biotechnology company in Boston is looking for a skilled Facilities Manager to join them for a 6-month project scheduled to start in September 2025.
The Facilities Manager is responsible for managing the operations and maintenance group to ensure that the equipment is operated and maintained in compliance with current Good Manufacturing Practices (cGMP)/current Good Laboratory Practices (cGLP) and industry standards. This consultant will perform both hands-on operation and maintenance activities as well as supervisory functions for a small team (2-3 people). The Facilities Manager is responsible for delivering FDA compliance and excellent customer service in a 24-hour manufacturing environment within a prescribed budget.

Responsibilities:

• Manage operations and maintenance program for FDA licensed manufacturing facility and associated research and development operations. This includes:
• Operation, maintenance, troubleshooting and repair of cGMP manufacturing and support equipment.
• Development of routine operating and maintenance methods.
• Establishment of preventive maintenance schedules and tasks.
• Generation, review and revision of operating and maintenance SOPs.
• Scheduling and documentation of maintenance and repair activities through a computerized maintenance management system (CMMS).
• Managing the daily schedule according to the priority of requests, operating conditions, and the availability or manpower and materials.
• Consistently meet target metrics for operations and maintenance programs.
• Specify and procure operations and maintenance-related tools, standards, instruments and equipment.
• Adhere to budgets, schedules and performance requirements.
• Manage multiple contracts with outside vendors performing operations and maintenance on various types of equipment.
• Maintain maintenance and operations records, equipment identification and tagging.
• Write and implement change controls to maintain cGMP compliance.
• Write incident/deviation reports as necessary, performing root cause analyses and identifying corrective actions as appropriate.
• Serve as technical advisor on equipment issues.
• Perform additional job-related duties as required.

Requirements:

• BS degree minimum
• Ability to work onsite every day, 40 hours/week
• 5+ years of experience working with Biotechnology or Pharmaceutical companies (cGMP environment) in a Facilities Manager role
• Strong mechanical background in troubleshooting the following equipment: autoclaves, clean room air handlers, WFI, pumps, clean steam, etc.
• Proven supervisory capability
• Excellent written and verbal communication skills

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Relocation assistance
• Vision insurance

Education:

• Bachelor’s (Preferred)

Experience:

• facilities management exp in pharma/biotech: 5 years (Preferred)
• autoclaves, clean room air handlers, WFI, pumps, clean steam: 5 years (Preferred)
• supervisory capability: 5 years (Preferred)

Ability to Commute:

• Boston, MA 02111 (Preferred)

Work Location: In perso

• Manage operations and maintenance program for FDA licensed manufacturing facility and associated research and development operations. This includes:
• Operation, maintenance, troubleshooting and repair of cGMP manufacturing and support equipment.
• Development of routine operating and maintenance methods.
• Establishment of preventive maintenance schedules and tasks.
• Generation, review and revision of operating and maintenance SOPs.
• Scheduling and documentation of maintenance and repair activities through a computerized maintenance management system (CMMS).
• Managing the daily schedule according to the priority of requests, operating conditions, and the availability or manpower and materials.
• Consistently meet target metrics for operations and maintenance programs.
• Specify and procure operations and maintenance-related tools, standards, instruments and equipment.
• Adhere to budgets, schedules and performance requirements.
• Manage multiple contracts with outside vendors performing operations and maintenance on various types of equipment.
• Maintain maintenance and operations records, equipment identification and tagging.
• Write and implement change controls to maintain cGMP compliance.
• Write incident/deviation reports as necessary, performing root cause analyses and identifying corrective actions as appropriate.
• Serve as technical advisor on equipment issues.
• Perform additional job-related duties as required