The ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. Our role is to be a companion on the road for technology teams to be able to use as a tool at times when decisions need to be made.
We now have an amazing opportunity for an experienced Packaging Engineer to join our growing team and work on site with one of our blue-chip multinational clients within the pharmaceutical industry. This role is a full-time role based out of one of our client sites in Dublin South.
The Position
The successful candidate will be a smart, enthusiastic individual who has a keen interest in developing their technical knowledge. The Automation Engineer provides technical support for all automated systems within the Packaging area.
Your responsibilities will include, but won’t be limited to:
* Work as part of a team to develop, implement and maintain packaging automation systems in our clients Manufacturing Facility.
* Develop, review and approve new and updated software standards.
* Provide automation expertise to the engineering and operations department on design and sustaining decisions.
* Liaise closely with internal stakeholders to successfully support packaging operations.
* Develop and implement standard operating procedures to ensure the future compliance of all automation systems.
* Ensure all new software is delivered and maintained in a compliant and qualified state.
* Provide support for validation activities.
* Participate in cross-functional teams to drive optimization of processes and equipment.
* Assist in training personnel on specific automation aspects of equipment.
* Design and implement solutions across automation platforms in line with the site change control procedures.
* Develop, review and approve design documentation that support New Product Introductions (NPI) projects.
Requirements:
* At least 5 years + experience within the automation industry supporting GMP environments and applications coupled with a Degree in IT, Science or Engineering.
* 3 years or more experience supporting a biopharma process.
* Knowledge of Automation systems design and experience of developing system architectures to support NPI.
* Direct experience in managing and working alongside system integrator.
* Experience with SQL Server and virtualization platforms is a plus, as is IT experience.
* Experience with vendors Seavision is preferred.
* Previous experience with China Serialisation (China encoding) is a plus.
* Direct experience and in-depth knowledge of packaging automation and vision systems platforms is required.
* Direct experience in supporting a manufacturing facility.
* Experience of implementing change controls and investigating deviations/events.
* Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices (GAMP) to ensure site automation systems are cGMP compliant.
* Full understanding of automation system implementation and validation life cycle along with an understanding of the product quality impact of changes.
* A full valid Irish work permit is required for this role as it is an immediate start.
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