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.
