Position Details We are seeking a motivated and detail-oriented Graduate Engineer to join our team at a EU GMP compliant vaccine manufacturing facility.
This is an exciting opportunity to be involved in validation, qualification, and routine support of critical equipment and cleanroom environments.
Key Responsibilities: Temperature Mapping and Environmental Monitoring:
• Plan, execute, and document temperature mapping studies for storage areas (cold rooms, freezers, incubators, warehouses) and critical process equipment.
• Perform risk assessments to define mapping strategy and sensor placement.
• Analyze data for compliance with EU GMP and internal quality standards.
• Generate and review validation protocols and reports (IQ/OQ/PQ).
Autoclave Load Qualification:
• Support the qualification of autoclaves, including moist heat sterilization cycles.
• Develop and execute load patterns and thermal distribution/equilibration studies.
• Ensure Biological Indicators (BIs) and thermocouples are placed per GMP requirements.
• Analyze cycle performance data and support requalification activities.
Equipment Qualification and Validation:
• Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment (e.g., HVAC, clean steam, washers, filling lines, isolators).
• Support validation life cycle documentation and change control processes.Collaborate with cross-functional teams (QA, Manufacturing, Maintenance).
Cleanroom and Facility Support:
• Support routine cleanroom qualification (HEPA integrity testing, airflow visualization, pressure differential monitoring).
• Participate in periodic requalification and deviation investigations.
• Assist in maintaining the state of control of classified environments.
Other duties as assigned.
Documentation and Compliance:
• Prepare and review engineering documentation in compliance with EU GMP Annex 15, EMA, and FDA standards.
• Completion of work orders in the engineering system
• Follow Good Documentation Practice (GDP) and support audit readiness.
• Contribute to continuous improvement initiatives and deviation/CAPA investigations.
Essential Education and Experience:
• Bachelor's degree in Mechanical, Chemical, Biomedical, or Process Engineering (or equivalent).
• Strong interest in GMP-regulated pharmaceutical/biotech manufacturing.
• Familiarity with validation principles and GMP guidelines (e.g., Annex 15, ICH Q8/Q9/Q10).
• Proficient with Microsoft Office.
• Excellent attention to detail, analytical mindset, and willingness to learn.
• Strong written and verbal communication skills.
Desirable Education and Experience:
• Internship or co-op in a regulated manufacturing or laboratory setting.
• Experience with GxP documentation or working in a cleanroom environment.
• Basic understanding of equipment like autoclaves, clean steam systems, HVAC systems, and temperature control devices.
To learn more about Phibro Animal Health's competitive benefits package, please click here: .