Clean Utilities

Clean Utilities:
 
PharmEng Technology is currently seeking a Clean Utilities assist our team for projects in Durham, NC.
 
 
 
Overview of Position:
The purpose of this role is to be a clean utilities Engineer supporting a current client at a sterile facility and a working background in that industry is preferred. This is a key role to help ensure that the day to day operations of the Utilities provided to the site are compliant


 
Job Description:
  • Support audits on clean utility systems
  • Be responsible for adherence to site and corporate QMS for clean Utility Systems
  • Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses
  • Complete periodic reviews and other compliance documentation aligned with the site QMS.
  • Review and approve Utility & HVAC modifications, change requests, and SOP’s
  • Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan
  • Represent the Utilities engineering group and lead highly technical cross-functional teams and work across utilities engineering areas to deliver robust and sustainable solutions and business processes
  • The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems)
  • Drive functional commitments on initiatives and provide high level of oversight and coordination to seamlessly integrate utility engineering efforts within the site
  • Consult with other subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny
  • Act as the utilities engineering expert and technical consultant to management in identifying opportunities, prioritizing work and will make sound recommendations for design and construction solutions
 
Job Requirements:
  • At least 5 years’ experience in the Pharmaceutical industry or a similar operating environmen
  • Degree or 3rd Level Qualification (Engineering)
  • Desirable to have qualification in Reliability Engineering and/or Project Management
  • Bachelor of Engineering in a related discipline
  • Strong Compliance Mindset, demonstrated capability of understanding EHS & GMP compliance requirements (particularly from an Engineering perspective), demonstrated capability within the Audit environment (specifically EHS & GMP)
  • Very Strong Leadership Skills
  • Technical knowledge
  • Ability to respond to competing priorities
  • Communications skills
  • Problem solving skills
  • Ability to prepare budgets and tightly control expenditures
  • Relevant experience in pharmaceutical production management
  • Very strong knowledge of industrial safety standards
  • Beneficial to have previous operational knowledge within Drug Product, Drug Substance or Utilities
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Engineering, Manufacturing or Quality etc.)
  • Knowledge and experience in applying Six Sigma and Lean Methodologies
  • Demonstrated leadership and change management skills with a continuous improvement focus
  • Proven experience in reducing energy consumption through innovative technology and lean thinking
  • Demonstrated understanding of Project life Cycle , from design through to commissioning/qualification & retirement
  • Strong talent developer, proven capability of fostering engineering/technical talent
  • Beneficial to have strong networks within Engineering/Technical community
  • Customer Focus – proven ability to delight customers & end users
 



 
 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
 
 
 
 
 
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