Serialization Specialist/Operations Continuous improvement Support

3 weeks ago

Cluain Meala, County Tipperary, Ireland Pinewood Healthcare Full time

KEY RESPONSIBILITIES

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

Engineering
  • Continuous Improvement: Assist in analyzing and improving production processes to enhance efficiency and reduce waste.
  • Data Collection and Analysis: Gather and analyze data related to production performance, quality control, and cost management.
  • Project Support: Support strategic project delivery in planning, support, and execution.
  • Quality Assurance: Support implementation and development of quality control procedures (e.g., SOPs, work instructions) to ensure products and processes meet standards.
  • Support the production department with market complaints, deviations, and CCFs.
  • Prepare technical reports, documentation, and presentations to support project development and implementation.
  • Collaborate with cross-functional teams including production, quality, and supply chain to implement process improvements.
  • Support on-line project implementation to ensure effectiveness and sustainability.
Serialization Support
  • Configure, implement, and maintain serialization and track-and-trace systems.
  • Provide first-line and escalated support for serialization-related technical issues, diagnosing and resolving hardware and software failures.
  • Collaborate with IT, production, and engineering teams to resolve system downtimes.
  • Complete system validation activities, including IQ, OQ, and PQ documentation.
  • Analyze production and packaging line processes to optimize serialization workflows.
  • Ensure compliance with regulatory requirements (e.g., EU FMD).
  • Provide internal support for system users, troubleshooting, and resolution of routine issues.
  • Assist with the implementation of new systems and upgrades.
  • Complete validation activities related to new system implementations or changes.
  • Support new product introduction projects.
  • Manage serialization database and review pack specifications.
Skills and Qualifications
  • Qualifications Framework (QQI) Level 7 or above in Engineering, Operational Excellence, or related field.
  • Strong analytical skills to analyze data and identify trends.
  • Excellent problem-solving skills; applying Six Sigma tools to improve processes, reduce defects, and increase efficiency.
  • Excellent communication, documentation, and interpersonal skills.
  • Experience with SOPs, work instructions, and change control documentation is desirable.
  • Knowledge of serialization software (e.g., SaTT Platform) is desirable.
  • Six Sigma Belt certification is preferable.
  • Strong IT skills.

This role offers an opportunity to develop skills across multiple departments, supporting manufacturing process and system optimization. It is an excellent development opportunity for candidates aiming to enhance their skill set and career.

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