Beschreibung
Job Title: Technical Specialist Fill and FinishStart Date: 01.02.2019 or 01.03.2019
Duration: 12 Months, extension might be possible
Location: Bern, BE
Job Description
Main responsibilities
- The position holder acts as Fill Finish Process Engineer reporting to the Head of Fill Process Technology.
- Within the Project Team he/she is responsible to transform production requirements into technical solutions through Detail Design, Construction, Qualification, Commissioning and productive Start Up for the fill finish building C.
- He/she supports construction management, qualification and commissioning team, Automation team and others with subject matter expert know how to enable the project to progress efficiently.
- Involved systems and equipment are Vial washer, Depyrogenation tunnel, Aseptic Filling machine with Isolator Technology, Freez Dryer loading systems with Isolator, Freeze dryer, Autoclaves, Washing machines, Visual inspection equipment, Freeze and Thaw unit, Cleanrooms etc.
- He/she coordinates closely and proactively with manufacturing (customer).
- He/she supports engineering services (Maintenance) with setting up Maintenance schedule and activities.
Technical Responsibilities
- Liaises with manufacturing (customer) on the project to ensure delivery according to user requirements, process best practices, in accordance with quality and safety requirements.
- Interacts and coordinates with equipment suppliers, Automation, Construction Company, commissioning and qualification teams in terms of our Fill finish processes and equipment.
- Support of the Maintenance Groups in the definition of the maintenance system and the maintenance schedule for equipment within the Fill finish building.
- Ensure that the Facility design intent is reflected within quality-driven design deliverables and in accordance with the Project Brief, User Requirements, Local Authority conditions and Global Regulatory requirements & industry best practice.
- Responsible and accountable for working according to cGxP, health, safety and environmental requirements as laid out in the companies SOPs and procedures as well as all relevant external / governmental guidance.
- Contributing to the delivery of the company strategy as well as supporting the financial CapEx budgeting process for the engineering and Project Management Organization.
- Defines technical requirement specifications in coordination with manufacturing department dealing with the Fill Finish processes.
- Technical support for procurement, FAT & SAT of all process equipment & skids.
Health and Safety
Behaves with discipline to adhere to safety policies, safety rules, practices and behaviors as instructed/rolled out by the safety function (EHSS) and endorsed by the site management. Actively promotes the contribution of his/her department to support safety initiatives and to execute on safety issue reporting, near miss reporting and EHSS KPI reporting.
Requirements
Education
- Bachelor Degree in mechanical, process or chemical engineering, Dipl. Ing. or M.Sc. or B.Sc. or equivalent.
Experience
- At least 3 years' experience in engineering field in food or pharmaceutical industry required.
Additional Requirements
- Experience gained with the design, procurement, construction, commissioning & qualification of process equipment in food or pharmaceutical industry. Experience in Fill Finish environment is preferred.
- Experience in cGMP, GDP and qualification processes.
- Languages: German and English fluent in writing and spoken.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.