Manager, Calibration & Planning/Scheduling

Job Locations US-MA-Bedford
Posted Date 4 months ago(2/24/2020 8:43 AM)
Job ID
2019-1286
# of Openings
1
Category
Operations

Overview

The Manager, Calibration & Planning/Scheduling will be responsible for the management of the Metrology/Calibration Program and the Computerized Maintenance Management System (CMMS) in support of formulation, development and commercialization of innovative therapies at a GMP biopharmaceutical manufacturing plant. 

Responsibilities

 

Responsibilities and duties include:

  • Responsible for specification and selection of instrumentation and controls for GMP manufacturing equipment and utilities as well as for general facilities, non-GMP.
  • Responsible for metrology and calibration design and operating tolerances, calibration ranges and frequencies.
  • Provide instrumentation and control design requirements, specifications and procedures for all life cycle phases of manufacturing, utility and facility equipment instrumentation.
  • Work independently to create robust metrology and calibration standard operating procedures (SOP) for the commissioning, validation and operation of instrumentation and controls.
  • Develop and maintain inhouse calibration capability.  Build inhouse capability to calibrate and maintain instrumentation and controls for planned and corrective calibrations.
  • Develop and maintain inhouse instrument maintenance capability for all reliability and corrective equipment instrumentation and controls requirements.
  • Maintain calibration outsourcing capability.  Review and selection of calibration vendors, assurance of adherence to all Ocular safety, quality and compliance requirements.
  • Provide lead on metrology, instrumentation & controls and calibration on all capital projects for Engineering, Procurement, Construction, Commissioning and Validation (EPCCV).
  • Responsible for instrumentation and controls reliability program.  Development of onsite instrument spare parts program.   
  • Evolve and maintain Blue Mountain CMMS for electronic scheduling and documentation of all planned and corrective maintenance activities with electronic cross-functional review and approval.
  • Responsible for development of CMMS calibration job plans.
  • Develop standard operating procedures for CMMS administration and operation.
  • Responsible for management of calibration and instrumentation maintenance staff and contracted services.
  • Assist Director of Facilities on capital and expense budget planning and spending in support of metrology, calibration and CMMS activities. Provide hands on preventative and corrective maintenance of mechanical, instrumentation and control (I&C) devices and systems. 
  • Support site change controls, deviations and investigations on all instrument and controls related initiatives and events.
  • Investigate major instrument or equipment related problem areas and determine best course of action for resolution, including out-of-tolerance reports and investigations
  • Ensure maintenance and calibration histories are easily retrievable to support regulatory inspection requirements
  • Represent metrology and calibration during all regulatory audits.
  • Other duties as assigned.

Qualifications

  • Minimum of 10 years in metrology, calibration in the pharmaceutical industry
  • Experience in manufacturing, utility and facility equipment maintenance
  • Experience in a Good Manufacturing Practice (GMP) manufacturing facility
  • Management and or leadership roles in support of project and sustain operation in metrology and calibration discipline
  • Proficient in Microsoft applications.
  • Experience with a Computerized Maintenance Management System (CMMS)
  • Experience with calibration planning and scheduling
  • Proven team collaboration experience
  • Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to biotechnology product/device manufacturing and disposition
  • Position requires the ability to work with instrumentation, electrical and mechanical equipment and lift up to 30 lbs.
  • Must be able to work in both cleanroom and chemical laboratory environments.
  • Position requires working with chemicals

 

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