Description
Job description:The Validation Specialist is responsible for equipment cleaning and autoclaving cycle development, manufacturing controls implementation, equipment prep process qualification and manufacturing resource training in the site.
Responsibilities:
* 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 on site cleaning verification & validation programs compliant with USFDA requirements.
* Write and execute cleaning characterization, 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:
* 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.
If you are interested in this role please contact Sarah Irvine directly on .