Manufacturing Process Specialist
7 days ago
We are seeking an experienced Process Engineer to support a high-profile project in Cork. As a key member of the team, you will focus on manufacturing process validation, quality system updates, and documentation remediation. This role involves working directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
Key Responsibilities
- Analyse process, product, material or equipment specifications and performance requirements
- Compile and analyse operational, test and experimental data to establish performance standards for newly implemented or modified products / processes
- Summarise, analyse and draw conclusions from test results leading to effective technical resolution
- Troubleshoot new products / process working closely with product development
- Continually seek to drive improvements in process design, layout and operational performance
- Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements
- Actively promote and participate in cross-functional teamwork environments
- Evaluate new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
- Understand and comply with all regulations governing quality systems
- Evaluate new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
- Actively promote and participate in cross-functional teamwork environments
- Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements
- Continually seek to drive improvements in process design, layout and operational performance
- Troubleshoot new products / process working closely with product development
- Summarise, analyse and draw conclusions from test results leading to effective technical resolution
- Compile and analyse operational, test and experimental data to establish performance standards for newly implemented or modified products / processes
Required Skills and Qualifications
- Engineering or Quality degree with 2-3 years' relevant industry experience
- Background in remediation, process validation, CAPA, NCRs.
- Strong technical writing and documentation skills.
- Knowledge of 21 CFR Part 820, ISO 13485.
Benefits
- Competitive employee compensation package
- Pension contributions
- Health insurance
- Paid public holidays
Location: Cork, Ireland | onsite
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