Description
VALIDATION SPECIALIST - BIOTECH - SCOTLAND - Central Belt - CONTRACT - £35-£50 PER HOUR
Biomedical - Scotland - Edinburgh - Glasgow - Livingston - Stirling - Falkirk - Hamilton - Dunfermline - Validation
My client is looking for a Validation Engineer with 5 years+ experience in the industry to head up their global validation team in Scotland.
The Head of Validation will manage validation activities for the site and be Responsible for ensuring that all equipment, software, process and product is validated in accordance with EU and other international regulatory and quality standards as appropriate.
Other duties will include:
*Managing validation projects, executed either by internal staff or external contractors
*Creation of and maintenance of validation procedures for the site
*Ensure that all equipment is consistently validated according to the applicable rules (EU, BRA, CHN and USA)
*Developing an effective master validation strategy with cross functional input and creating validation protocols and reports (URS, DQ, IQ, OQ, PQ) and other applicable documentation
- 5 + years in a Healthcare, Pharmaceutical or Medical Device industry and educated to degree level or higher
- Excellent analytical and troubleshooting skills with experienced in FMEA, Hazard Analysis, Fishbone or similar failure investigation methodologies
- Experience in the some or all of the following: CIP, autoclave validations, HVAC, EtOx validations, mixing validations for formulation vessels, experience with Kaye instruments, experience of fermentation, SIP, media fills
- Excellent communication and interpersonal skills with the ability to interact with all levels of the organization. Ability to operate independently as well as part of a team
PLEASE CONTACT EUAN WILSO