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Clean Utilities Compliance Engineer

Job Title: Clean Utilities Compliance Engineer
Contract Type: Permanent
Location: Cork
REF: 91198
Job Published: 9 months ago

Job Description

Contact: Anne Gough
Telephone: 086 0449473

Clean Utilities Compliance Engineer
Our client, a medical device company in Cork are currently looking to recruit a Clean Utilities Compliance Engineer for their site.

Purpose of Role
The purpose of this role is to be a clean utilities SME as to assist with any queries in relation to design standards, engineering guides or other technical/compliance documentation in relation to clean Utilities. This role will play a key part to ensuring compliance of the site clean utilities.

Activities within Role:
  • Be responsible for adherence to site and corporate QMS for clean Utility Systems
  • Be the site SME for audits on clean utility systems.
  • Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses.
  • Ensure capital project delivery is adherent to QMS for clean utilities and designed in accordance with relevant engineering standards.
  • This position will identify and implement best practices during capital project execution.
  • 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.

Continuous Improvements:
Use Lean principles to deliver a cost efficient operating model for commercial production while not compromising EHS and Quality standards.

Coaching and Training:
Coaching others by sharing your skill-set and expertise. Identifying talent and coaching and nurturing them to develop and perform at their maximum potential

Job Experience:
  • At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment.

  • Degree or 3rd Level Qualification (Engineering), Masters preferred.
  • Desirable to have qualification in Reliability Engineering and/or Project Management.
  • Bachelor of Engineering in a related discipline.

Skill-Set Expected:
  • Strong Compliance Mind-set, 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.

For further information on this Clean Utilities Compliance Engineer role in Cork please contact Anne Gough on 086 0449473 /
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