Fastnet The Talent group are currently recruiting for a Changeover Specialist with a multinational Pharmaceutical client based in Cork. Chemical Process engineers desired, excellent opportunity for a candidate with 1-2 years relevant expeirence.
The change-over of equipment trains from product to product is a key activity for the site. Excellence in the safe and efficient change-over of equipment trains from product to product plays a key role in the delivery of products to the markets.
Working as part of the Change-over team, your role will be to:
- Provide process technical support in order to sustain & improve the changeover processes on site
- Coordinate all GMP aspects of the postMI, ensuring the required documentation is in place prior to the start of the change-over , ensuring 100% Manufacturing Right First time during the postMI and implementing sustainable CAPAs following any deviations.
- Work closely with the Operations, Safety, Engineering, Quality Operations and Value Stream Teams to ensure change-overs are executed with zero SIIs and zero defects.
- Effectively use the site business processes to support and to monitor the postMI process e.g. change control, deviations, 6 sigma Method 1 investigations, Area Information Centres etc
- Work with the Change-over team in leading in the implementation of key change-over projects for the site, targeted at reducing the sites change-over time.
- Align change-overs to Standard Work Plans and lead other Lean initiatives to reduce the overall change-over time on site
To be successful in this role, you will need:
- A relevant 3rd Level qualification and/or significant experience in a pharmaceutical environment
- A demonstrated ability to proactively problem solve solutions to Engineering and Quality scenarios.
- A proven knowledge of GMP procedures and the requirements of change controls, Standard Operating Procedures, document control, etc.
- An ability to deal with process change and to implement new and effective processes.
- Demonstrated applications of Lean and Six Sigma tools would be an advantage.
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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