Description

  • Develop and establish maintenance/engineering tools/programs to ensure that the facility is kept in a good state of repairs as well as all process equipment are cGMP compliant from a facility, maintenance and engineering perspective.
  • Direct, evaluate and assist capital engineering and process improvement projects.
  • Facilitate requisitions or equipment and parts.
  • Serve as equipment/facility expert and interface with regulatory agencies on audits etc.
  • Develop efficient PM plans for all key pieces of manufacturing equipment etc. and provide troubleshooting expertise in all areas of plant operations and maintenance.
  • Assist in and or champion investigation of deviations that are facilities/maintenance related, Train SMEs in problem solving techniques and ensure the appropriate corrective actions are taken.
  • Assist in writing regulatory documents for FDA submission as required
  • Continuously monitor the manufacturing operation to look for process optimization, debottlenecking opportunities and make technical engineering recommendations and/or changes as necessary.
  • Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval.

Qualifications:

  • Bachelor’s degree in Mechanical, Biochemical, or Chemical Engineering.
  • Minimum 5 years of process engineering/project engineering experience in a cGMP, Pharmaceuticals, Biological manufacturing environment.
  • Must have the ability to apply engineering theory, practices and principles to determine root cause of equipment failures and to perform equipment performance evaluations

Key Skills
Education

Bachelor's degree

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