API Cleaning & Process Validation Engineer

EFOR; Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

EFOR in Cork is seeking a Process/Cleaning Support Engineer to provide technical support for cleaning validation, process improvements, and manufacturing operations ensuring GMP-compliant production of APIs. You will develop protocols, execute validation activities, and document results.

You will work with Quality, Validation, and Production teams, contribute to risk assessments and CAPAs, and help prepare technical reports, SOPs, and batch records.

Qualifications

• Requires GMP knowledge and understanding of cleaning validation principles.
• Experience in documenting technical reports and regulatory compliance.
• Experience supporting API manufacturing environments.

Responsibilities

• Provide technical support for cleaning validation activities, including protocol development, execution, and documentation.
• Support process optimization projects and troubleshooting related to API manufacturing.
• Review and assess cleaning requirements, strategies, and procedures in GMP compliance.
• Collaborate with Quality, Validation, and Production to resolve cleaning and process issues.
• Assist in risk assessments, root cause analysis, and CAPA implementation.
• Prepare and review technical reports, SOPs, and batch records.
• Participate in change control, deviation, and investigation processes.
• Support regulatory inspections and internal audits with documentation and explanations.

Skills

Problem-solving

Analytical skills

Communication skills

Teamwork

Documentation skills

Education

Bachelor’s degree in Chemical Engineering, Biochemistry, or related discipline

Job description

EFOR in Cork is seeking a Process/Cleaning Support Engineer to provide technical support for cleaning validation, process improvements, and manufacturing operations ensuring GMP-compliant production of APIs. You will develop protocols, execute validation activities, and document results.

You will work with Quality, Validation, and Production teams, contribute to risk assessments and CAPAs, and help prepare technical reports, SOPs, and batch records.