Introduction
We at Traque are on an exciting journey of growth and are looking for a dynamic
Validation Engineers
to help us achieve our vision to become your first-choice industrial solution provider.
Traque provides comprehensive consulting and engineering solutions, working with multinational pharmaceutical clients to R&D facilities - across all spectrums of the industry from chemical API, secondary, biopharmaceutical to medical device designers and manufacturers.
Key Duties:
The Validation Engineers are responsible for validation of biopharmaceutical equipment, facilities, utilities, laboratory equipment and computer systems in new and modified pharmaceutical and life science facilities.
This includes working or leading a team, supporting the purchase, installation, commissioning and qualification of biopharmaceutical equipment, utilities and processes.
Sourcing, specification and selection of new equipment based on minimal user input
Coordinating with vendors and working with the design teams to ensure a fit for purpose system
Managing installation and commissioning of the equipment (with vendor support)
Qualification of the equipment, including: - preparation of protocols and test plans, execution of the protocols including sample and reagent preparation, preparation of qualification summary reports, and investigation of deviations
Supporting process technical transfer: - including feasibility studies, equipment sizing, process design, process validation and process optimisation
User training in equipment use and operation
Supporting cleaning and process validation studies, including cleaning strategy development, protocol development, execution assistance
Job Requirements
University degree in Engineering, Life Sciences or equivalent
Minimum 3 years' experience in commissioning and/or validation of biopharmaceutical equipment and processes
Experienced working in a pharmaceutical or GMP/GLP environment is preferred, although cross-industry expertise is welcomed
Preferably experienced with using Kneat
Experienced working under Quality Management Systems
Excellent interpersonal and communication skills
Goal-oriented, dynamic, and high sense of responsibility
Able to work flexibly and under pressure
Able to work self-reliantly
Possess excellent customer-oriented work-ethic
Professional appearance and demeanor
Very good written and verbal English skills
Immediate availability is preferred
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