Position Summary
Responsible for managerial direction and technical leadership of all GMP Maintenance needs. Supports current GMP manufacturing production including maintenance of utility systems, HVAC, BAS, process equipment, and new product introduction.
Job Responsibilities

• Develops, trains, and maintains direct reports to perform a variety of duties including preventive and corrective maintenance.
• Coordinates with internal departments to ensure manufacturing operations are compliant with all internal and external quality, regulatory and customer requirements related to GMP maintenance.
• Provides direct supervision of maintenance personnel responsible for support of operations, clean utilities, and finished product manufacturing operations.
• Sets group policy regarding staffing, hours, and job functions to meet the needs of planned projects and operations.
• Plans GMP maintenance activities, assigns tasks, reviews work, writes appraisals and provides technical training.
• Ensures that maintenance personnel are trained and qualified to perform assigned duties
• Ensures that preventive and corrective maintenance is performed in an efficient and timely manner.
• Presents departmental updates as required to senior management, including tracking or quality metrics and KPIs.
• Participates in regulatory inspections, acting as the maintenance SME when required.
• Perform continuous personal and department personnel development to improve maintenance and management skills.
• Department recruiting, talent development, training and retention.
• This position may be involved with the transportation and handling of hazardous waste.

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Education Requirements*
Associate degree in an Engineering/Maintenance related field, or equivalent experience.
Experience Requirements

• Direct GMP maintenance experience with process equipment and utility systems.
• 10+ years experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP maintenance, CGMPs and FDA regulatory guidelines.
• Excellent management skills and ability to drive projects and teams to desired results.
• Possess high level of accountability to complete projects on time and under budget.
• Must be flexible to work any shift and overtime, including weekends.
• Must be available (on call) 24/7 for emergency situations.

Job Type: Full-time

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