Manager, Equipment Maintenance & Calibration

Role Summary

Manager, Equipment Maintenance & Calibration. Location: Eden Prairie, MN (onsite). Responsible for development and execution of maintenance, calibration, technical oversight, and asset management operations, including equipment procurement, troubleshooting, and ongoing performance analysis to improve reliability. Provide engineering/GxP administration for RAM in support of maintenance and projects.

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 SOPs, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, FAT, SAT, and 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
• Perform gap analysis of validation documentation, systems, and practices. Recommend and implement corrective actions and improvements
• Support site audits/inspections (internal and external) as directed by Operations/QA to represent facilities and calibration departments
• Direct the development of an SOP review and alignment strategy. Manage facilities, calibration, and tech services leads to maintain all utilities equipment and calibration SOPs to ensure GMP compliance
• Develop, implement, and maintain a maintenance training program. Ensure cross-training across GMP and non-GMP systems and equipment and facility life safety systems
• Direct the development of system/equipment reliability program and metrics to track infrastructure upgrades, and make recommendations to improve reliability and minimize downtime
• Direct and manage direct reports including training, goal setting, performance evaluations, coaching, and recruitment support as needed
• Perform other duties as assigned

Qualifications

• 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
• 2+ years of people management experience
• Organizational skills and systems implementation knowledge
• Solid fundamental computer skills in word processing and spreadsheets
• Ability to work in a team environment and collaborate across the organization
• Demonstrated ability to analyze and solve technical problems
• Effective verbal and written communication skills
• Experience using metrology tools and standards

Education

• Preferred: Bachelor's Degree in metrology, or relevant engineering field of study

Additional Requirements

• Job location: Eden Prairie, MN (onsite)
• Travel: Not specified