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Scientific. Clinical. Software Engineering

Facilities Quality Engineering Manager

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -042020-26721 Region: Newark Metro Area

Job Description

Facilities - Quality and Reliability Engineering Manager

  • Provides technical expertise, troubleshooting and improved equipment maintenance/reliability strategies to optimize safe, compliant, and efficient operations of all facility and utility equipment and instrumentation.
  • Prepares asset files including equipment data sheets, impact assessments, P&ID & drawings, factory O&Ms, factory maintenance recommendations, maintenance work plans and procedures.
  • Manages any CAPAs associated with the CMMS, including PMs or Calibrations performed late or out of conformance
  • Initiates deviations for maintenance work orders that are out of compliance or that is monitored by the BEMS
  • Assist in the development and management of a facility document management program to track facility drawings, and project turnover packages.
  • Lead on facility workstream to support large-scale project asset and maintenance plan management.
  • Generates SOPs and Work Practices within company s Document Management System to establish the Use, Maintenance and Calibration plans for GMP equipment.

Requires:

Strong knowledge of critical utility systems such as compressed gas, vacuum, waste, as well as security and key managements systems and policies

Strong knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems).

Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.

Familiarity with FDA / cGXP environments and associated compliance regulations

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