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Serialization specialist/operations continuous improvement support

Clonmel
Pinewood Healthcare
Posted: 23 June
Offer description

KEY RESPONSIBILITIES

The Serialization Specialist and CI Engineer will be responsible for the support and administration of Pinewood's global serialization systems, focusing on the technical aspects of serialization and track and trace. The main responsibilities include:

1. Engineering:
1. Continuous Improvement: Assist in analyzing and improving production processes to enhance efficiency and reduce waste.
2. Data Collection and Analysis: Gather and analyze data related to production performance, quality control, and cost management.
3. Project Support: Support strategic project delivery, including planning, support, and execution.
4. Quality Assurance: Support the implementation and development of quality control procedures (e.g., SOPs, work instructions) to ensure products and processes meet standards.
5. Support Production Department with Market Complaints, Deviations, and CCFs.
6. Documentation: Prepare technical reports, documentation, and presentations for project development and implementation.
7. Collaboration: Work with cross-functional teams, including production, quality, and supply chain, to implement process improvements.
8. Support on-line project implementation to ensure effectiveness and sustainability.
2. Serialization Support:
1. Configure, implement, and maintain serialization and track-and-trace systems.
2. Provide first-line and escalated support for serialization-related technical issues, diagnose and resolve hardware and software failures.
3. Collaborate with IT, production, and engineering teams to resolve system downtimes.
4. Complete system validation activities, including IQ, OQ, and PQ documentation.
5. Analyze production and packaging line processes to optimize serialization workflows.
6. Ensure compliance with regulatory requirements (e.g., EU FMD).
7. Provide internal support for system users, troubleshooting, and resolution of routine issues.
8. Assist with the implementation of new systems and upgrades.
9. Complete validation activities related to system implementation or changes.
10. Support new product introduction projects.
11. Manage serialization database and review pack specifications.
3. Skills and Qualifications:
1. Education: Qualifications Framework (QQI) Level 7 or above in Engineering, Operational Excellence, or related fields.
2. Analytical Skills: Strong ability to analyze data and identify trends.
3. Problem-Solving: Excellent problem-solving skills; apply Six Sigma tools to improve processes and reduce defects.
4. Communication: Excellent documentation, communication, and interpersonal skills.
5. Technical Writing: Experience with SOPs, work instructions, and change control documentation (desirable).
6. Knowledge of Serialization Software (e.g., SaTT Platform) is desirable.
7. Six Sigma Belt is preferable.
8. Strong IT skills.

This role offers an opportunity to develop skills and gain experience across multiple departments, supporting manufacturing process and system optimization. It is an ideal development opportunity for candidates seeking to expand their skill set and advance their careers.

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