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Packaging Process Engineer II – Alajuela

Smith & Nephew · Coyol

🇬🇧 English
ISO 11607 SAP ECN system Material research Sterilization testing

Job description

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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Published 4 months ago

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Smith & Nephew

Coyol