Description
Job Responsibilities:Commissioning and Qualification of critical utilities including:
DI Water
Compressed Air
Nitrogen
HVAC
Commissioning and Qualification of equipment and qualification of laboratory equipment
Commissioning and Qualification documentation generation, review and approval.
Validation Project Plans FMEAs/Risk Assessments
User Requirement Specification
Functional Design Specification
Factory Acceptance testing
Site Acceptance Testing
Commissioning Test Plans
IQ, OQ and PQ protocols and reports Investigations
Review of computer system validation documentation for upgrade to laboratory equipment software and utility PLCs.
Education and Experience Required for Role:
Third Level Degree
Minimum of 5 years experience in the medical device/pharma industry in a validation role.
Very good interpersonal, communication and presentation skills, along with an ability to deliver on targets and deadlines.
Proficient in the use of MS Office and Chromatography systems software.
Degree qualification in relevant science and / or engineering discipline.
If you are interested in this role please contact Sarah Irvine directly on .