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.
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
- 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.
- 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 / email@example.com
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