Job Description
Phibro Animal Health Corporation is a global organization with a rich history in animal health and nutrition. We provide solutions to help maintain and enhance animal health by being a trusted partner with livestock producers, farmers, veterinarians, and consumers.
We strive to be a diversified company with manufacturing and marketing products for various markets. Our revenues are substantial, supported by 2,300 employees worldwide.
At Phibro, people are our greatest asset. We foster an environment where creativity and skills can thrive, making us successful.
The Graduate Engineer is a critical member of our Engineering team based out of Sligo, Ireland. We seek a motivated Graduate Engineer to join our EU GMP compliant vaccine manufacturing facility.
This role involves validation, qualification, and routine support of critical equipment and cleanroom environments.
Key Responsibilities
* Temperature Mapping and Environmental Monitoring:
o Plan, execute, and document temperature mapping studies for storage areas and critical process equipment.
o Perform risk assessments and define mapping strategy and sensor placement.
o Analyze data for compliance with EU GMP and internal quality standards.
o Generate and review validation protocols and reports.
* Autoclave Load Qualification:
o Support the qualification of autoclaves, including moist heat sterilization cycles.
o Develop and execute load patterns and thermal distribution/equilibration studies.
o Ensure Biological Indicators and thermocouples are placed per GMP requirements.
o Analyze cycle performance data and support requalification activities.
* Equipment Qualification and Validation:
o Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
o Support validation life cycle documentation and change control processes.
o Collaborate with cross-functional teams.
* Cleanroom and Facility Support:
o Support routine cleanroom qualification and periodic requalification.
o Participate in deviation investigations and assist in maintaining classified environments.
o Other duties as assigned.
Documentation and Compliance
* Prepare and review engineering documentation in compliance with EU GMP Annex 15, EMA, and FDA standards.
* Complete work orders in the engineering system.
* Follow Good Documentation Practice 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.
* Strong interest in GMP-regulated pharmaceutical/biotech manufacturing.
* Familiarity with validation principles and GMP guidelines.
* 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.