Beschreibung:For one of our Swiss Pharma clients we are looking for temporary support as:Senior Process Engineer GMP (M/F/*)
Responsible for process engineering work packages during the design, construction and startup of a new green-field, large scale manufacturing facility
Responsibilities will include supporting the design development, procurement, factory acceptance testing, installation, commissioning, qualification and validation of new process systems and equipment utilized in the production of biopharmaceutical drug substance.
Drive the development and execution of test plans and protocols for FAT, SAT, commissioning, qualification and validation.
Oversee and or/lead commissioning within assigned areas, including equipment inspections, factory acceptance testing (FAT), site acceptance testing (SAT), field verification walk-downs and commissioning test execution.
Oversee and/or lead equipment and system mechanical completion walk-downs, safety walk-downs, system energization plans, lock-out tag-out, and review and approval of turnover packages (TOP).
Lead the turnover of systems for subsequent validation activities and provide technical support throughout validation activities.
Provide process engineering input during design development, construction, testing, commissioning, qualification 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.
Create professional atmosphere by cooperation with peers within Process Engineering, building of knowledge system and coaching junior engineers.
Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management.
Degree in Biochemical, Chemical, or Mechanical Engineering
Must have minimum of 10 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.
Priority placed on good communication and relationship skills.
English required, and fluency in German or French or Italian preferred.
Duration: until 02.02.2021
Capacity: 42 h/week onsite
Location: Solothurn, Switzerland
Bemerkungen:WANTED: Senior Process Engineer GMP. In case of interest please contact email@example.com or +41 71 577 27 41. Skills:Engineer (Biomedical Engineer), English, GMP (Good Manufacturing Practice), Process Development & Optimization