Manager, Equipment Maintenance & Calibration

Role Summary

Lead maintenance and calibration operations for GMP equipment as the Manager, Equipment Maintenance & Calibration. You will oversee preventive maintenance, calibration, and validation activities; coordinate with production and lab schedules; manage equipment lifecycle documentation and vendor communications; and provide RAM/GxP administration support for maintenance projects. This role is onsite in Eden Prairie, MN.

Responsibilities

• Oversee and support preventative maintenance and keep accurate records of work completed
• Manage writing/completing equipment SOPs, change controls and deviations for GxP engineering and facilities operations
• Effectively communicate technical issues with equipment vendors and supporting departments during troubleshooting activities and maintenance/repair visits
• Execute and support calibration and validation efforts for production area equipment and processes
• Coordinate calibration and validation activities, serve as the validation subject matter expert in specific areas of equipment validation
• Collect, compile, analyze, and review data in support of validation activities. Analyze and interpret data and information through more sophisticated or in-depth analysis to confirm the validated state of the equipment for GMP use with some or minimal supervision.
• Develop, execute, and review various types of equipment lifecycle documentation, including but not limited to: SOPs, Master Plans, User Requirement and Functional Requirements Specifications, Design Specifications, FAT, SAT, and Design Qualification (DQ), IQ, OQ, PQ, PV protocols and reports. Provide execution and documentation oversight of junior team members.
• Work independently on problems of diverse scope where analysis of data requires identification of root cause events. Select methods and techniques for problem-solving and decision-making.
• Perform gap analysis of validation documentation, systems, and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
• Support site audits/inspections (both internal and external authorities) as directed by Operations/QA to represent facilities and calibration departments
• Direct the development of an SOP review and alignment strategy. Support managing facilities, calibration, and tech services leads to maintain all utilities equipment and calibration SOPs to ensure compliance with GMP standards, quality systems and that SOPs align with in-house vs. contracted services.
• Develop, implement, and maintain a maintenance training program. Ensure staff is cross-trained across both GMP and non-GMP systems and equipment and on facility life safety systems. Create internal and external training recommendations to develop technicians to improve in-house capabilities.
• Direct the development of system/equipment reliability program and metrics to track infrastructure upgrade needs. Make recommendations for utilities systems upgrades to drive reliability and efficiency improvements and minimize system downtime.
• Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)
• Perform other duties as assigned

Qualifications

• Required: Associate Degree in metrology, or relevant engineering field with 10+ years of relevant industry experience OR a Bachelor's Degree in metrology, or relevant engineering field with 8+ years of relevant industry experience
• Required: 2+ years of people management experience
• Required: Organizational skills and systems implementation knowledge
• Required: Solid fundamental computer skills needed in word processing and spreadsheet handling
• Required: Ability to work in a team environment and ability to collaborate with others throughout the organization
• Required: Demonstrated ability to analyze and solve technical problems
• Required: Effective verbal and written communication skills
• Required: Experience using metrology tools and standards
• Preferred: Bachelor’s Degree in metrology, or relevant engineering field of study

Education

• Associate Degree in metrology, or relevant engineering field
• Bachelor’s Degree in metrology, or relevant engineering field