Beschreibung
External Posting Title Process EngineerLocation Solothurn, Switzerland
Duration: 6 months
Start Date: as soon as possible
Key Responsibilities:
- Develop test plans and protocols for FAT, SAT, commissioning and validation.
- Lead commissioning within assigned areas, including equipment inspections, factory acceptance testing (FAT), site acceptance testing (SAT), field verification walk-downs and commissioning test execution.
- Provide equipment and system mechanical completion walk-downs, safety walk-downs, system energization plans, lock-out tag-out, and review and approval of equipment installation manuals (EIM).
- Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management.
- Provide process engineering input during design development, construction, testing, commissioning and validation, and help manage changes through the project.
- Review and approve process engineering specifications, including process piping & instrumentation diagrams (P&IDs), datasheets, and procurement packages for new equipment and systems.
- Review and approve equipment vendor submittals, including system piping layouts, general arrangements and other equipment specifications and drawings.
- Lead the turnover of systems for subsequent validation activities and provide technical support throughout validation activities.
- Understand and implement internal policies, procedures and specifications as required for the execution of process engineering for the project.
- Interface with stakeholders to ensure the design, execution and delivery are in accordance with Global Engineering, Quality, Environmental and Safety procedures.
Qualifications
- Must have minimum of 7 years related experience in engineering, construction, commissioning and validation in a GMP / pharmaceutical / biotech manufacturing environment, or an equivalent combination of education and experience
- Must have demonstrated capability to provide engineering technical support for GMP facilities including cell culture, purification and biopharmaceutical processing equipment and clean utilities
- Must be able to travel up to 20%
- Priority placed on good communication and relationship skills
- English required, and fluency in German or French or Italian preferred.
- Education Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing Advanced degree strongly preferred
If you are interested please contact me under:
or
Regards
kajaBlomberg
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.