Commissioning and Qualification Engineer

Commissioning and Qualification Engineer

Westport Co. Mayo, Ireland

Opportunity:

NIRAS seeks a proactive and hands on Commissioning and Qualification Engineer who will help in the implementation of New Clean Utilities Systems. Successful applicant will be responsible for Generation, Execution and Approval of Qualification documents for Facility, Utility and Equipment systems and generation of Commissioning Test documents for non-direct Systems at our clients advanced Aseptic Sterile Manufacturing, Biologics site in Westport. Co. Mayo

Requirements:

• 3 years of Commissioning and Qualification experience, ideally working in a pharmaceutical or medical device manufacturing organization.
  
  
• Kneat validation system knowledge is an advantage.
  
  
• Proven track record working within a fast paced GMP environment.
  
  
• BS Degree in Engineering, Science or Technical discipline.
  
  
• Experience with Clean Utilities, Hygienic Piping, Process Instrumentation, Controls and TOPs is mandatory.
  
  
• Familiarity with risk-based approach to commissioning and qualification preferred.
  
  
• Familiarity with project management tools advantageous.
  
  
• Previous experience with Clean Utility tie-ins to existing systems is desirable (i.e Upgrading of existing Purified Water Skids to support tanks).
  
  
• Practical knowledge of Sanitary Equipment, Hygienic Piping, Process Instrumentation and Controls.
  
  
• Adherence to cGMP and cGDP is mandatory.
  
  
• Strong technical writing skills are essential.
  
  
• Able to work independently with limited supervision – self-sufficiency is critical.
  
  
• Demonstrable strong interpersonal & teamwork skills.
  
  
• Flexible in supporting unexpected project demands and maintain overall program schedule.
  
  Main systems in scope of support:
  
  
• WFI Distillation, Storage and Distribution
  
  
• Purified Water
  
  
• POU Coolers
  
  
• Partswasher
  
  
• Sterilization Autoclave
  
  
• VHP
  
  
• Freezers
  
  
• Facility qualification
  
  Who We are:
  
  NIRAS Ireland specializes in design and delivery of process-driven projects. We provide Project Management, Engineering Design, Project and Managed Service resources to the Life Science, Food & Beverage and Advanced Process Manufacturing sectors across Ireland and internationally. NIRAS employs over 3000 permanent staff and a pool of 25,000+ experts across our network. With 51 offices in 32 countries, NIRAS is committed to building long-term partnerships and capabilities where we work. A Value-Driven, Multi-Disciplinary Engineering Consultancy, NIRAS is fundamentally committed to Sustainable Progress and Service Delivery.
  
  What We Offer
  
  To work with an internationally renowned and long established Danish Engineering Consultancy
  
  To work on a diverse portfolio of interesting process projects with high levels of responsibility
  
  To secure follow on longer-term contracts as part of our Managed Services group.
  
  If you are a motivated and experienced C&Q Engineering professional looking to work on cutting edge technology projects, we encourage you to apply and come join our team.
  
  For a confidential discussion regarding this and our many other exciting opportunities with NIRAS Ireland, please contact Philip Cahill at (phone number removed)