Process Technician Serialisation Job at PCI Pharma Services (Stamullen)

Job Description

The Process Serialisation Technician will have important roles on supporting production for improving operational efficiency through accurate data management, troubleshooting serialisation hardware and software issues, anticipating serialisation issues in NPI implementations and ensuring PCI Serialisation process is in accordance with actual regulatory compliance. He will also support developing other stake holders in serialisation process and will lead implementation of continuous improvement actions to optimize the serialization process, reducing downtime and costs associated rework.

Job Responsibility

Act as the Subject Matter Expert (SME) for assigned serialisation processes within the technical function of Engineering
Display strong technical ability and have interpersonal and communication skills that build the strongest of relationships at department and site level
Have a proven track record in troubleshooting serialisation equipment issues (Hardware and Software)
Be capable of understanding and optimising system performance
Be strong in a team environment and possess excellent coordination skills

Requirements

Take responsibility for an assigned serialisation process(es) and become the site SME educating and training others
Work with vendors to better understand the technology and seek to maintain and optimise it’s capability
Assist and or lead Continuous Improvement (CI) Projects and operational issues as required
Population and maintenance of the Technical Drawing & serialisation equipment specification data base
Manage serialization data, including master data attributes, and address data transfer issues
Support the development of PCI internal serialisation processes/workflows
Build, develop and sustain the knowledge, capability and competency within the Engineering team
Ensure compliance with all serialisation regulatory requirements and manage serialisation data to maintain compliance
Support serialisation system validation activities and maintain relevant documentation
Support the risk management process through involvement in risk assessment
In conjunction with Operations lead or support technical, product and process reviews
Support the implementation of new serialization systems and upgrades
Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and technical standards, procedures and systems
Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviours
To undertake such tasks and to manage specific or ad hoc projects as and when required
The job holder is responsible for adhering to the company’s SOPs, Health & Safety, cGMP and other regulatory guidelines
The job holder is responsible for managing and maintaining capital project budgets

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Process Technician Serialisation

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