Description
Responsibilities include:* Create cleaning cycle development strategies and qualifications for a variety of equipment including: automatic parts washer and autoclaves
* In situ equipment cleaning process development /qualification
* Aseptic process simulation, cleaning development and verification, Responsible for planning and execution of onside cleaning verification & validation programs compliant with US FDA requirements
* Write and execute cleaning characterisation , degradation , verification ,IQ/OQ/PQ/ and cycle development protocols including development of final reports
* Develop & implement operational SOPs for the equipment & process
* Perform risk assessment and gap analysis for site cleaning programs
* Perform process documentation review , performance monitoring , data analysis /trending including verifying calibration and in-process data
* Perform spray coverage testing, cleaning verification swabbing and risk sampling
Qualifications required:
* BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
* Must have experience with equipment cleaning and autoclaving technology expertise
* Must have Aseptic process simulation experience, cleaning development, verification and SIP validation.
* Proven experience with: cleaning verification , characterisation (e.g. degradation studies etc.) validation, protocol development, execution, troubleshooting, and summary reports
* Excellent technical writing in particular around deviation, protocol and report writing is required.
* Industry experience related to cGMP drug manufacturing, validation, programming, or chemical process design
* Strong computer knowledge including Microsoft Office products