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+ years 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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