Cleanroom Manufacturing Engineer


Cork
Contract
Negotiable
Manufacturing
CR/589968_1777043379
Cleanroom Manufacturing Engineer

Position Summary
Under the general direction of the Engineering Manager, the Manufacturing Engineer is responsible for supporting the introduction and scale-up of new products within a cleanroom assembly environment. This role focuses on developing, validating, and optimizing manufacturing processes to ensure efficient, compliant, and high-quality production. The Manufacturing Engineer will work cross-functionally with Design, Quality, and Operations teams to support New Product Introduction (NPI) from concept through to full production. This is an onsite role.
Contract: 12-23 months, Full time, primarily on-site, day rate contract, start mid-June

What You Will Do:

  • Support New Product Introduction (NPI) activities, including process development, equipment selection, and production readiness for cleanroom assembly.
  • Develop and maintain manufacturing process documentation, including work instructions, SOPs, process flow diagrams, and validation protocols.
  • Collaborate with cross-functional teams (R&D, Quality, Supply Chain, and Production) to ensure smooth transfer from design to manufacturing.
  • Assist in the design and implementation of cleanroom-compliant assembly processes, ensuring adherence to contamination control and regulatory requirements.
  • Participate in process validation activities (IQ/OQ/PQ) and support execution of validation protocols and reports.
  • Identify and implement process improvements to enhance yield, efficiency, and product quality within the cleanroom environment.
  • Troubleshoot and resolve process, equipment, and product issues, performing root cause analysis and implementing corrective and preventive actions (CAPA).
  • Support line setup, pilot builds, and production ramp-up, ensuring processes are stable and capable.
  • Work with Quality Assurance to support non-conformance investigations, deviations, and audit readiness.
  • Monitor key performance metrics such as yield, cycle time, and defect rates, and take appropriate action to address gaps.
  • Assist in managing engineering changes (ECRs/ECNs) and ensure proper implementation on the production floor.
  • Provide technical support and training to production operators and technicians within the cleanroom environment.
  • All other duties as assigned.

What You Will Need:

  • 2 years'+ experience in a manufacturing engineering role.
  • Understanding of cleanroom operations and contamination control practices (experience is a strong advantage).
  • Knowledge of process validation (IQ/OQ/PQ).
  • Familiarity with manufacturing process development, including documentation and standardisation.
  • Strong problem-solving skills with experience in root cause analysis and continuous improvement methodologies (e.g., Lean, Six Sigma).
  • Ability to read and interpret engineering drawings, specifications, and BOMs.
  • Proficiency in tools such as MS Office, ERP/MRP systems, and basic data analysis tools.
  • Strong communication and teamwork skills, with the ability to collaborate across multiple functions.
  • Ability to work in a fast-paced NPI environment, managing multiple priorities and meeting deadlines.
  • Experience supporting cleanroom assembly processes is a distinct advantage.
  • Demonstrated ability to adapt to a dynamic, regulated manufacturing environment.

FAQs

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