Maintenance Clean Utilities Engineer

Job Location US-NY-Melville
ID
2018-3999
# of Openings
1
Category
Engineering
Type
Direct Hire

Overview

The Maintenance Clean Utilities Engineer will mainly focus on Maintenance program and troubleshooting GMP utilities.

Responsibilities

  • Assures business continuity supporting the maintenance and troubleshooting of the site GMP Utilities*
  • Provides technical expertise to the maintenance team on GMP Utilities*
  • Manages Service contracts related to GMP Utilities*
  • Ensures that site SOPs, Building Automation System alarms and controls related to GMP Utilities* are up to date and ensures that maintenance activities are executed with GMP standard eg water sanitization program
  • Build effective and collaborative relations with all functional areas in the plant.
  • Monitors spare parts related to GMP Utilities*
  • Support any deviation, corrective action, Investigation related to the GMP Utilities*
  • Supports any design study and oversees any installation/upgrade of GMP Utilities* on the site
  • As site SME for GMP Utilities* will be responsible of support any internal and external audit on the subject matter
  • Perform design studies, engineering test plans, troubleshooting, submitting Change Control Requests, and coordinating efforts with QA, Regulatory, Safety, Production, Validation, and
  • Maintains current knowledge of developments related to manufacturing and applies that knowledge to company
  • Makes independent decisions within defined area of GMP Utilities: Purified Water and Water for injection generation and distribution systems, Pharm air generation and distribution system clean steam generation and distribution system , Nitrogen generation and distribution system, Alcohol Still reclaim system, Alcohol distribution system, Acid and Caustic distribution systems, Methanol distribution system.

Qualifications

  • A minimum of 10 years of experience in a biopharmaceutical, or food, or OTC consumer industry in a role as project engineering, Certified Facility Manager (CFM) and/or Project Management Professional Certification (PMP) a plus.
  • Bachelor’s Degree in Engineering.
  • Deep knowledge of Microsoft Office, AutoCAD, Microsoft Project
  • Knowledge of FDA cGMP’s, Federal, State and Local Environmental regulations, standard operating procedures, QA/QC documentation, equipment validation, equipment specifications, factory acceptance testing, site acceptance testing, equipment start-up and

 

Knowledge, Skills, and Abilities

  • Strong communication and organizational skills
  • Demonstrated ability to effectively prioritize and coordinate functions and activities
  • Excellent project management skills.
  • Problem solving skills, results

 

 

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