Position Details

Job Purpose:
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.