Quanta Consultancy Services
Frankfurt am Main, Hessen, Germany
This employer requests that only candidates in Germany apply to this job.
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An initial 6-month contract for a Utility Engineer for a world leading biopharmaceutical company on their expansion of a sterile filling environment with scope for extension on an overall 2 year programme of works.
New 2 year program in which a world leading biopharmaceutical company are developing a new sterile processing area which involves cleanroom environment - HVAC and utility package, Clean utilities and HVAC installation & Qualification.
Duties/Deliverables/Measurable's for the role:
Act as a representative for the client during the delivery of the new project within the sterile processing area.
Interface with the Client throughout design, execution, and handover of the current projects.
Coordinate with other groups with responsibilities for process/project engineering activities, eg Commissioning/Qualification and Validation.
Provide up-to-date information to Line Management on activities and time- lines relating to project work, utilising appropriate techniques.
Provide technical expertise within the field of Utilities and HVAC/Cleanroom environments. Experience/Key Skills:
Experience within a highly regulated Pharmaceutical Manufacturing environment, with full life cycle experience on the delivery of Utility projects. (Clean Utility systems, WFI, PTW systems, Clean gases, Black Utility Systems, Air, Steam, Water systems, CIP/SIP, HVAC).
Previous experience of project life cycle activities to include generating URS's, Undertaking design reviews, PID's and support on the composition of Business cases.
Demonstrable experience in the support of drafting, executing and reporting of validation documentation ie IQ, OQ, PQ protocols during qualification of Clean Utility systems, WFI, PTW systems, Clean gases, Black Utility systems, Air, Steam, Water systems, CIP/SIP. HVAC. Laminar flows/Cabinets.
A focus on Technical Activities and Compliance/Validation.
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