Process/Cleaning Support Engineer (API)

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

We are seeking a Process/Cleaning Support Engineer to join our API manufacturing team in Cork. The successful candidate will provide technical support for cleaning validation, process improvement initiatives, and manufacturing operations to ensure safe, compliant, and efficient production of Active Pharmaceutical Ingredients (API).

Key Responsibilities:

• Provide technical support for cleaning validation activities, including protocol development, execution, and documentation.
• Support process optimization projects and troubleshooting efforts related to API manufacturing.
• Review and assess cleaning requirements, strategies, and procedures in compliance with GMP and regulatory guidelines.
• Collaborate with cross-functional teams, including Quality, Validation, and Production, to resolve issues related to cleaning and process operations.
• Assist in risk assessments, root cause analysis, and implementation of corrective and preventive actions (CAPA).
• Prepare and review technical reports, SOPs, and batch records pertaining to cleaning and process activities.
• Participate in change control, deviation, and investigation processes as required.
• Support regulatory inspections and internal audits, providing documentation and technical explanations for cleaning and process activities.
• Maintain knowledge of current best practices, regulatory requirements, and industry trends related to API production and cleaning validation.

Requirements:

• Bachelor’s degree in Chemical Engineering, Biochemistry, or a related discipline.
• Minimum 2 years’ experience supporting process/cleaning validation in pharmaceutical API manufacturing environment.
• Strong understanding of GMP, regulatory compliance, and cleaning validation principles.
• Proficient in technical/report writing and documentation.
• Excellent problem-solving and analytical skills.
• Effective communication and teamwork abilities.
• Familiarity with risk assessment and quality systems.
• Experience with API facility cleaning validation and process engineering support.
• Knowledge of regulatory standards (e.g. FDA, EMA).
• Experience working in a highly regulated manufacturing environment.