Mgr, Calibrations

Job Description

The Site Calibration Manager is a member of the Engineering Maintenance and Site Services (EMSS) team providing oversight to calibration employees and the calibration program at the Durham Site. This includes Energy Center Vaccines Manufacturing and Bulk Facilities Quality Labs and Maintenance and Material Storage Facility (MMSF). At times support may extend to the DurhamTeknika site when requested. This position will focus on managing calibration technicians ProCal System Oversight and assisting with successful execution of calibration activities.

General Profile:

Employee Development People Management

• People manager role with a moderate number of calibration technicians (1520) directly reporting

• Hire develop motivate and manage a team to ensure reliable manufacturing maintenance activities execution

• Assign yearly performance objectives 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 teams capabilities and maturity

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

• Acts as trainer for ProCal CCMS for incoming technicians and facilitates training opportunities for calibration activities.

Process Execution Continuous Improvement

• Contributes to the performance and results of the area departments as well as the site.

• Adapts departmental plans and priorities to address resource and operational challenges.

• Decisions are guided by policies procedures and business plan; receives limited guidance from manager.

• Project management manages area project priorities schedule & execution for routine and nonroutine work

Communication

• Actively lead Tier 1 Process (team daily huddle) and participate in Tier 2 (Org daily huddle) as required

• Coordinates with area schedulers to build calibration schedule for the team to follow for site activities.

• Anticipates and interprets client and/or customer needs to identify solutions

• Supports departmental shutdown meetings. Attends site daily shutdown meetings ensuring department owned activities are tracked and completed.

• Determines daily calibration priorities and coordinates project/work with the area maintenance schedulers.

Quality & Safety Compliance

• Review/Finalize calibrations in CCMS system

• Accountable for calibration metrics associated with execution and instrument performance.

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

• Safety permit approval for calibration activities

• Identifies revisions to the calibration program to ensure that calibration activities are completed in accordance with established safety GMP and calibration procedures.

• Expand knowledge into other systems capable of managing change in the pursuit of continuous improvement

• Supports investigations into instrumentrelated events and assists in identifying appropriate corrective actions (CAPAs).

The successful candidate must have strong problemsolving skills and a handson approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety compliance automation equipment process and people) in order to best understand and identify root cause.

This position is a 1st shift position with the potential for infrequent off shift work as needed to support business results. This position is expected to work as an independent member of an integrated team focused on achieving the teams objectives vision and goals.

Education Requirement:

• Masters Degree or higher in Engineering Science or related fieldand 4 years of experience in a calibration and/or maintenance background
  OR

• Bachelors Degree or higher in Engineering Science or related fieldand 6 years of experience in a calibration and/or maintenance background
  OR

• Associate degree or higher in Engineering Science or related fieldand 8 years of experience in a calibration and/or maintenance background
  OR

• H.S. Diploma maintenance craft skill training with 10 years of experience in a calibration and/or maintenance background

Required Experience and Skills:

• Strong planning scheduling and time management skills

• People Management experience and able to support technicians across multiple shifts.

• Familiarity of regulatory requirements in accordance with GMP manufacturing operations

• Good oral and written communication skills

• Experience with GMP compliant calibration and maintenance databases

• CCMS/ERP experience related to calibration/plant maintenance and spare parts procurement systems

• effects analysis (FMEA) and/or Lean Six Sigma tools.

• Familiarity of World Class calibration practices is paramount

• Experience in problem solving and troubleshooting

Preferred Experience and Skills:

• ProCal or similar system experience related to calibration execution and instrument addition

• Mechanical functionality and reliability knowledge (asset management)

• Experience with formal problemsolving techniques such as root cause analysis (RCA) failure mode

• Experience working in a clean room or GMP/regulated manufacturing environment

• Certified Maintenance Professional (CMRP CRL etc.)

#MSJR VETJOBS TechnicianDurham #EBRG

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Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

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