Description
Description:A multinational medical device company currently seeks an experienced Validation Engineer to join their team for a minimum 6 month contract. This position will be responsible for Ensuring that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements, and ensure successful validation of all manufacturing processes.
Execution of allocated validations according to the plant Validation Master Plan. Plant SME for Process Validation Execution
Role/Responsibilities:
Draft and Approve protocols and reports as required.
Execution of IQ, Process Development, OQ and PQ on new/revised processes as required
Publish site specific progress reports as required.
Liaise with Software Validation Engineer to create validation plans according to current toolkit
Create and control PFMEA and control plans throughout product life cycle
Participate in regular reviews of completed validations and advising suggested improvements in practice.
Assist with Process Development, conduct DOE and MSA
To link with Post Validation activities including closure of ACR and ECO (Change Control)
Support site change control procedures
Skills/Experience:
Degree in relevant Engineering or related discipline
A minimum of 5 years high volume engineering experience within Medical Devices.
A minimum of 2 years validation experience
Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes
Process development experience (DOE's etc)
Risk Analysis/Risk Management, FMEA's, etc.
Strong documentation skills, experience reviewing all validation reports and documentation
Strong working knowledge of GAMP5
Process validation training and experience
Strong technical and problem solving skills