Facilities Engineer

1 month ago


Warren, United States DPS Group Global Full time

Summary

DPS Group has an excellent opportunity for a Facilities Engineer to join our team in supporting our world-class, innovative BioPharma client in the Central, NJ area.


Responsibilities

  • Equipment Commissioning, Qualification, Validation.
  • Facilities/Utilities experience
  • Manufacturing Room Qualification
  • AHU's
  • Process Air and Carbon Dioxide Lines
  • Support project Equipment Validation (i.e. autoclave, bioreactor) – Lab/cGMP.
  • Familiarity with the user, functional, installation, operation, and performance requirements for assigned projects and tasks.
  • Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications), for use in the development of equipment commissioning and validation documents
  • Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.
  • Support Validation Master Plan development
  • Execution of equipment validation protocols (including use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.)
  • Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval.
  • Support Validation Summary Report development
  • Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system).
  • Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation.
  • Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).
  • Support resolution of engineering/validation issues found during equipment validation.
  • Attending meetings as required to support equipment installation and operation
  • Providing quality oversight and approval for validation documents as needed. (Function test, IQs, OQs, etc…)
  • Support developing SOP’s
  • Other tasks as requested or required to support the project
  • Other duties as assigned


Skills and Qualifications

  • Bachelor's degree in mechanical engineering or related engineering major
  • 2-7 years validation/facilities/utilities experience
  • Equipment Validation/CQV experience working within a cGMP & FDA Regulated environment is preferred.
  • A strong understanding and knowledge of equipment and automated systems
  • Previous experience working in a cGMP and FDA regulated environment
  • Performs other duties as assigned by management.
  • Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

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