Validation Engineer

Pay Range : $60 - $80 / Hour

Overview :

Initial length will be 12 months as there are two projects running through end of next year.

• Independent Engineer who has in depth knowledge about validation lifecycle management and be able to write VMP, protocols and corresponding summary reports
• Able to execute test protocols independently and resolve deviation and collaborate with engineering team, business process owner and QA to make changes if necessary. Able to investigate failure and write deviation and change control records.
• Experiences with qualification of systems that are integrated with PCS, such as but not limited to data acquisition systems, utilities and manufacturing equipment.
• Experiences with lifecycle documents authoring, protocol generation and execution for qualifying SIP / CIP systems, tanks (Stainless Steel and SUS), carbon depth filtration systems, tangential flow filtration systems and dispensing isolators. Capable of developing SIP and CIP cycles.
• Experiences with qualifying SCADA controlled system such as filling system.
• Experiences with room qualification per ISO-14644.
• In depth knowledge with GMP operations. Familiar with 21CFR Part 210 and 211, Annex 1, Annex 11 and 21CFR Part 11.
• Good communication and writing skills and able to work in team environment
• Able to work off hours (evening or overnight shifts) and weekends