API Cleaning & Process Engineer — GMP & Validation Expert

EFOR; Ireland; On-site; EUR 55,000 - 85,000; Full time

Job summary

EFOR in Cork seeks a Process/Cleaning Support Engineer to provide technical support for cleaning validation and process improvements in API manufacturing. The role focuses on ensuring compliant, efficient production through protocol development, documentation, and cross-functional collaboration.

Ideal candidates will have a chemical engineering background with at least 2 years in a regulated API environment, strong GMP knowledge, and solid problem-solving and writing skills.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemistry, or related discipline.
• Experience supporting process/cleaning validation in pharmaceutical API manufacturing.
• Familiarity with GMP, regulatory compliance, and cleaning validation principles.

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 cleaning requirements, strategies, and procedures in compliance with GMP/regulatory guidelines.
• Collaborate with Quality, Validation, and Production to resolve cleaning/process issues.
• Assist in risk assessments, root cause analysis, and CAPA implementation.
• Prepare and review technical reports, SOPs, and batch records for cleaning and process activities.
• Participate in change control, deviation, and investigation processes as required.
• Support regulatory inspections and internal audits with documentation and explanations.
• Maintain knowledge of best practices and industry trends in API production and cleaning validation.

Skills

Analytical thinking

Technical writing

Communication

Education

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

Job description

EFOR in Cork seeks a Process/Cleaning Support Engineer to provide technical support for cleaning validation and process improvements in API manufacturing. The role focuses on ensuring compliant, efficient production through protocol development, documentation, and cross-functional collaboration.

Ideal candidates will have a chemical engineering background with at least 2 years in a regulated API environment, strong GMP knowledge, and solid problem-solving and writing skills.