Description
HEY QUALITY ENGINEERS/ STERILIZATION EXPERTS-Do you want the opportunity to work for a rapidly growing CMO? Are you a Subject Matter Expert in Validation in aseptic/sterile environments? Are you a Sterilization & Qualification Pro? How is your working knowledge with semi-solids, liquids, and sterile injectables? If you like the sound of these questions and you are looking for a new contract opportunity then this ad is for you.My client is a leading contract development and manufacturing company that offers pharmaceutical companies the best range of capabilities and an excellent regulatory history. The company has 5 best-in-class cGMP locations and over 1,100 employees. Expansion is continuing and the Quality Sterilization Qualification Validation Engineer role has been created off the back of rapid company growth.
My client is looking for a Quality Sterilization/Qualification Validation Engineer
6 month contract. Temp to Hire opportunity. Competitive Rates.
The Job: Quality Sterilization/Qualification Validation Engineer
-VALIDATION: authoring and executing protocols, produce reports à support of validation/qualification of processes:
-Sterilization Processes: Vapor Hydrogen Peroxide, Autoclaves, Steam-in-Place, decontamination processes, dry heat sterilization
-Work with the lab, organizing testing, and delivering reports, organizing materials and all activities surrounding materials
-In charge of Failure activities: (lead) investigations, root cause analysis, CAPAs, completion and closure of investigations
-Generate final reports and be able to stand behind and support your work from a cGMP compliance perspective
Essential Skills:
-BS in Engineering, Life Sciences or relevant field
-Minimum 3 years performing the above duties in a pharmaceutical aseptic cGMP facility
-Extensive knowledge of Kaye Validator 2000
-Must know how to place/recover BIs (biological indicators)
- Experience with SEMI-SOLID and liquid dosage forms
To find out more about Real please visit www.realstaffing.com