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Packaging Process Engineer II – Alajuela
Smith & Nephew · Coyol
Description du poste
About the role
We are looking for a Packaging Process Engineer II to join our Alajuela site. You will support manufacturing teams, lead new product development projects and drive productivity initiatives for our packaging processes.
Key responsibilities
- Provide packaging process reliability through validation testing in compliance with ISO 11607.
- Collaborate with Manufacturing, R&D and Quality Engineers to meet aggressive timeline requirements.
- Write and execute IQ/OQ/PQ protocols, rework instructions, MPIs, BOMs, NCRs, routers and release documentation using the ECN system.
- Own CAPA issues related to the product line and implement proper packaging standards and procedures.
- Utilize SAP for inventory and product cost data to support business case analysis and resolve raw‑material issues.
- Update part drawings and specifications, work with IQA and vendors to prevent material problems.
- Train operators and engineers on technical and rework instructions, packaging sealing techniques and DOE studies.
- Support employee suggestion programs and drive cost‑saving initiatives.
Required profile
- Experience delivering packaging process validation and reliability.
- Proven ability to work with cross‑functional engineering teams.
- Experience writing and managing IQ/OQ/PQ documentation.
- Familiarity with CAPA management and ECN processes.
- Ability to use SAP for inventory and cost analysis.
- Experience troubleshooting raw‑material issues and updating technical documentation.
Required skills
- ISO 11607 compliance
- SAP (inventory and product cost modules)
- IQ/OQ/PQ protocol development
- CAPA management
- ECN system usage
- Design of Experiments (DOE)
- Material research and sterilization testing
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Smith & Nephew
Coyol