Job Description
Validation Engineer
Duties:
- Lead Development and execution of CD and PQ requirements for new projects.
- Develop and execute Requal protocols for various Thermal
Systems (Autoclave, SIP, CTUs) - Lead investigations on validation deviations
where required. - Identify and Implement Continiuos improvents inititives.
- Adhere to site EHS standards and reporting requirements.
Requirements
Skills:
competences and qualifications:
1. Direct
Experience with hands on qualification of Steam Sterilization Autoclaves and
porous loads
2. Understanding
of the EN285 Requirements and testing
3. Understanding
of the Saturated Steam requirements, heat transfer and Sterilization kill
kinetics
4. Understanding
of the Cycle Development and Performance requirements for the Porous Load
sterilization
5. Understanding
and handling of the Biological Indicators used for Steam Sterilization
6. Understanding
of the SIP (Steaming/Sterilization in Place) system design and SIP CQAs
7. Direct
Experience with hands on for SIP qualification
8. Understanding
of the Filter Integrity Testing requirements for SIP applications
9. Direct Experience
with hands on qualification of Depyrigenation Tunnel
10.
Understanding of the Endotoxins and thermal Requirements for Depyrogenation
cycle (dry heat)
11. Direct
Experience with execution of Control Temperature Units and qualification
requirements
12. Direct
Experience using thermal acquisition systems
13.
Understanding of the Aseptic Manufacturing processes
14.
Understanding of the Quality System Elements:
a.
Deviation
b. CAPA
c.
Calibration
d. Preventative
maintenance
e. Change
Control
APPLY NOW