Activities Within Role:
- 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).
- 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.
- Support audits on clean utility 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.
Qualifications Skills & Experience:
- Degree qualification (Mechanical/ Process and Plant Technology/ Chemical Engineering).
- Lean Six Sigma qualification or experience of application of Lean principles is an advantage.
- 2/ 3+ Yrs Pharmaceutical Industry Experience working in a similar.
- Experience of working with multi-disciplined teams.
- Good Written and verbal communication skills.
- Identify key stakeholders and develop a relationship of trust.
- Solid engineering and business acumen.
- Demonstrated capability to communicate effectively across multiple teams
- Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
- Confident and effective decision maker, with a proven ability to influence others.
- Excellent presentation and written / verbal communication skills.
- Team player, with a flexible approach.
- Ability to work autonomously.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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