The Company
Scorpius BioManufacturing is an innovation-driven contract research, development and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.
POSITION SUMMARY
Reporting directly to the Vice President of Operations, the Maintenance Manager will be responsible for building and leading the maintenance team in ensuring the safe and efficient operation of all equipment and facilities in the biotech manufacturing plant. The Maintenance Manager will also be responsible for all aspects of the company’s maintenance strategy. The Maintenance Manager will work closely with other department managers to ensure that the plant is operating efficiently, and that all equipment and facilities are in compliance with regulatory requirements.
KEY RESPONSIBILITIES
- Provide expertise in the implementation of a Computerized Maintenance Management System (CMMS).
- Develop and implement maintenance programs for all equipment and facilities in the biotech manufacturing plant.
- Manage maintenance schedules to ensure that all equipment and facilities are properly maintained and available for use.
- Develop and implement company strategy for maintenance outsourcing.
- Oversee the maintenance budget to ensure that resources are being used effectively and efficiently.
- Ensure that all maintenance activities are in compliance with regulatory requirements, including FDA regulations.
- Lead a team of maintenance technicians and engineers to ensure that maintenance activities are carried out safely and efficiently.
- Identify areas for improvement in maintenance processes and implement changes to increase efficiency and reduce downtime.
- Develop and maintain relationships with equipment suppliers and service providers to ensure that the plant has access to the latest technologies and maintenance services.
- Work closely with other department managers to ensure that the plant is operating at peak efficiency and that all equipment and facilities are properly maintained.
- Ensure that all maintenance records are properly documented and maintained.
EDUCATION & EXPERIENCE
- Bachelor's degree in engineering or related field.
- At least 5 years of experience in maintenance management in a biotech or pharmaceutical manufacturing environment.
- Experience in implementing and managing a CMMS.
- Experience in managing outsourcing of maintenance activities.
- Experience managing maintenance budgets and schedules.
KNOWLEDGE & SKILLS
- Strong leadership and communication skills.
- Familiarity with FDA regulations and cGMP requirements.
- Strong problem-solving skills and ability to work in a fast-paced environment.
- Ability to work independently and as part of a team.
PHYSICAL REQUIREMENTS and working Environment
- Flexibility is required for working hours. Some earlier or later start/finish times may also be required.
- While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds.
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