Freeze-Drying Operations
1. Execute freeze-drying cycles according to the production plan.
2. Monitor all freeze-drying cycle parameters to ensure optimal and compliant operating conditions.
3. Operate freeze driers for both routine production and test cycles.
4. Perform visual checks and review graphical data to confirm correct system performance.
GMP Documentation & Compliance
5. Complete all GMP documentation accurately and in a timely manner.
6. Report abnormal trends, alarms, or deviations via SCADA data and follow defined escalation pathways.
7. Prepare and compile freeze-drying cycle records for inclusion in batch manufacturing documentation.
8. Initiate deviation reports and support investigations into unexpected variations.
Process & Equipment Support
9. Assist in optimizing lyophilization processes to improve efficiency and reliability.
10. Monitor key utilities (pressure, levels, flow) to ensure uninterrupted operations.
11. Load consumables and maintain required inventory for freeze-drying support systems.
12. Perform basic equipment interventions (, clamp adjustments, nitrogen filter changes, leak checks).
13. Report utility or equipment alarms promptly to enable rapid maintenance response.
Environmental Monitoring
14. Monitor environmental conditions in cleanrooms and support areas via FMS.
15. Identify abnormal trends and ensure appropriate escalation according to SOPs.
16. Compile routine environmental monitoring printouts for QA review and approval.
Additional Production Activities
17. Support other production-related operations during low lyophilization activity periods.
Health & Safety
18. Follow all emergency procedures and safe systems of work.
19. Adhere to EH&S requirements and maintain strong safety behavior.
Experience & Qualifications
20. ONC in Electrical, Mechanical, Electronic Engineering, or Instrumentation.
21. Experience in a pharmaceutical environment, ideally with freeze-dryer operations.
22. Strong understanding of cGMP.
23. Proficiency with SCADA systems and computerized process monitoring.
24. Experience operating equipment with multiple cycles and complex functionality.
Key Attributes
25. Detail-oriented, methodical, and highly disciplined.
26. Strong judgment based on SOPs, validated parameters, and experience.
27. Ability to work independently within a 24/7 shift pattern and take accountability for repetitive critical operations.
28. Clear written and verbal communication skills.
29. Willingness to seek cross-functional support when needed to maintain process reliability.
Ready to make an impact?