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Form of workJob Description
The Maintenance & Facilities Supervisor reports to the Facility Engineering Manager to support the Technical Operations group in a wide range of maintenance and engineering work. The position performs duties under limited supervision and according to cGMP and standard operating procedures. The position participates in: performing calibrations and preventive maintenance; scheduling and escorting outside services for calibrations, repairs and preventive maintenance; coordination with local stakeholders; writes Standard Operating Procedures (SOPs); supports technical investigations of deviations; and leads small engineering and maintenance projects. The candidate should be a highly motivated self-starter who is comfortable working in a hands-on environment.
Responsibilities:
- Responsible for identification and implementation of preventative and predictive maintenance systems
- This system is required to ensure that plant and facility equipment operate efficiently to minimize production interruptions and unscheduled downtime
- Develop and manage facility and maintenance department capital and expense budgets for the Manufacturing sites
- Manage major capital investments in plant and facility expansions by identifying the project’s requirements, setting objectives and timelines, handling the budget, and developing strategies to optimize project operations
- Engineering and facility management of the building and micronizing facility for US operations
- Manage project and process engineering staff plus outside consultants supporting facility and capital projects
- Schedule inspections and repairs with outside vendors as needed
- Ensure compliance with safety practices and government regulations as they pertain to the normal operating activities of the facility including FDA GMP/Quality Assurance policies and procedures
Technical Proficiencies:
- Participate (or lead small) CAPEX/OPEX/CI projects including but not limited to:
- Provide risk assessment for new systems and changes to existing systems
- Write simple project execution plans
- Execute startup/commissioning activities (e.g., write commissioning report, review/approve TOPs, create/update/review/approve SOPs)
- Technical reviews of protocols and periodic monitoring
- Lead or participate in project team including the supervision of contractors
- Provides estimates of resource requirements
- Optimization & Compliance
- Responsible for technical optimization of the field of care
- Ensures that the facility equipment, machinery, documentation, and technical support meets the compliance, quality and EHS standards
- Contributes to, supports, or leads BPE/MPE activities to ensure a continuous optimization process
- Supports implementation and improvement of best practice of technical standards, procedures
- Participates in peer-to-peer reviews
