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If you are an experienced Process Engineer with Clean Utilities, Black utilities and Process Equipment, within the pharmaceutical sector then this role is perfect for you.
The responsibilities of the successful validation engineers will include:
- Responsible for follow-up the installation and qualification activities of Clean Utilities, Black Utilities and Process Equipment
- Responsible for finding solutions to any problems that arise during the IQ/OQ activities
- Assess and evaluate the design and the operation of process equipment (Fermentor, Ultrafiltration unit, Washing Pit, vessels, etc) and supply systems (WFI, LPW, PS, NaOH, CAP, etc).
- Responsible for the testing, operating equipment and systems
- Assess equipment and processes, collect and review data, and conduct tests to see how the processes can be improved.
- Ensure correct implementation and follow-up of C&Q (Commissioning & Qualification) approaches/strategy of several technical packages in compliance with FDA, EMA and International quality standards
- Commissioning of equipment / systems on site and all associated documentation, check the pre-requisites
- Responsible for the validation steps (until the end of OQ) and the review of C&Q documentation, track related incidents / changes
- Ensure respect of GMP, GDP and GEP during C&Q activities
- Communicate with Engineering Office and Vendors according to GSK requirement, expectations
- Control and evaluate external staffs work
- Technical and quality supervision of the validation process of the equipment involved in project
- Advanced level degree (graduate chemist, chemical engineer, biologist or equivalent)
- GMP and Process Engineering skills
- Fluent written and spoken English
- High user level computer skills (Word, Excel)
- Good communication and problem-solving skills, accuracy, precision
- Previous experience working with Clean Utilities, Black Utilities and Process Equipment
- Previous experience of working within a cGMP/Hungarian regulated environment
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
A Leading biotechnology company with a major CAPEX biotech investment in Eastern Europe requires a Track wise Project Manager to represent the client on this large scale project and provide vendor
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