Senior Validation Engineer

Senior Validation Engineer

Validation Engineer Senior/Computer Systems Validation Engineer Senior required to start ASAP. 3 month contract initially, to be based in Inverness. Full time. Previous experience working in a regulated industry carrying out computer systems validation and/or testing activities. Minimum of two years working in an FDA regulated environment carrying out computer systems validation and/or testing activities. Knowledge of bespoke computer software and/or hardware specification, testing and documentation. Knowledge of the specification, testing and implementation of automated equipment with integrated and networked software applications. Software risk assessment and risk based testing methods. Experience in document authoring of validation deliverables. Self-directed; ability to work with minimal direct supervision, Verbal and written communications, Negotiation, Problem-solving, Proactive problem resolution, Change Management, In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485:2003 and European regulations associated with the medical device industry, In depth knowledge of GAMP 5.

Role Purpose: 
To provide validation support for the validation activities associated with computer systems ensuring that all compliance issues and requirements of LifeScan Validation Policies and Procedures are addressed.

Responsibilities: 
To coordinate projects associated with the validation of computer systems [IT, Control and End user] as directed
To organize and lead Validation working parties associated with computer systems, providing a timely validation coordination service to Project Managers or identified Project Leaders
To provide support and input to CSV Team Leader to work towards a LifeScan common computer systems validation process
To provide information on current regulatory and company standards that must be met to achieve and maintain compliance
To prepare and issue Validation Master Plans, Protocols, Summary Reports and other documentation associated with validation of computer systems, as appropriate for each validation exercise
To ensure all validation activities and documents are authorised and appropriate compliance approval is gained
To ensure that all validation activities are carried out and reported in a timely manner
To compile a Validation Master File for each computer system as appropriate.
To assure compliance through assisting in audits
Through effective communication and training initiatives develop staff within projects and validation teams to ensure that validation projects are carried out in accordance with LifeScan Policies and Procedures
To schedule and complete validation reviews for each computer system.
To facilitate, encourage and coordinate continuous improvement with respect to validation activities within the team
Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee healthability to work with minimal direct supervision
Verbal and written communications
Negotiation 
Problem-solving
Proactive problem resolution
Change Management
In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485:2003 and European regulations associated with the medical device industry
In depth knowledge of GAMP 5