Maintenance/Calibration Manager

Job Description

The Maintenance/Calibration Manager is a leadership opportunity within the Engineering/Maintenance team supporting a new drug substance manufacturing operation.  The individual in this role must provide direction, coaching, and technical expertise to maintenance and instrumentation technicians assigned to start up and maintain the new facility (process, utility and automation assets). This individual must actively manage his/her team to reliably support customer demand (including employee development, routine coaching sessions, recognition, and performance management). Additionally, the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to resolve process/equipment issues, minimize downtime, and ensure product quality.  This role actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.

Responsible for supporting:

• Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)

• Support Equipment (e.g. washers, autoclaves, tube welders/sealers)

• Process Utility Systems (e.g. Clean-In-Place (CIP) Systems, Water for Injection (WFI), and Clean Steam (CS))

• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)

• Maintenance Equipment (e.g. tools and calibration equipment)

• Act as an SME for maintenance operations

Employee Development / People Management:

• Hire, develop, motivate, and manage a team to ensure reliable maintenance/calibration execution.

• Assign yearly performance objectives and track metrics for the team in alignment with department and site goals

• Provide regular feedback and coaching to employees on work performance

• Provide leadership to the team as needed based on the team’s capabilities and maturity

• Ensure on time approval of payroll activities using site approved software like ADP

• Ensure that training and certification are assigned and completed as expected

Quality & Safety Compliance:

• Foster strong safety culture on the team through actions, coaching, and prioritization

• Participate in safety/regulatory audits (i.e. tours, topic discussion)

• Coach individuals when reporting safety issues and completing corrective/preventative actions

• Drive culture of compliance through actions, consistent quality-driven decision making, and coaching of the team (e.g. documentation, housekeeping, area 5S, etc.)

Process Execution / Continuous Improvement:

• Provide a leadership presence on the manufacturing floor

• Champion standard work to drive consistent use of best practices across teams

• Regularly help the team troubleshoot issues to minimize downtime and maintain product quality

• Represent maintenance and reliability input on project teams, as needed

• Strong sponsor for the problem-solving efforts and solutions offered by other shifts and teams

• Subject Matter expert for LOTO and permit writing for maintenance activities, Safety Management Information Systems (SMIS) transactions

• Knowledge of mechanical/electrical maintenance and repair of mechanical, electrical and automated systems and equipment 

• Actively lead the daily Tier 1 Process and participate in the Tier 2, as required

• Initiate SOP/PM/Calibration redlines and revisions

• Support planning of work to be scheduled

• Be in constant communication with Stakeholders to ensure no deviation from scheduled work.

Communication: 

• Lead and support daily meetings to facilitate flow of information up/down through the organization

• Hold regular team meetings to cascade information and collect team feedback

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