POS 3890
Status 5

Senior Process Engineer GMP

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: Senior Process Engineer GMP (M/F/*)
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  • 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. 
  • Qualifications:
  • 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.
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Frame Data:
  • Start: immediately
  • 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 or +41 71 577 27 41. Skills: Engineer (Biomedical Engineer), English, GMP (Good Manufacturing Practice), Process Development & Optimization
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Interesse geweckt?
Auf geht's!
Beginn: 03.08.2020
Laufzeit: 6 months
Einsatzort: Solothurn, Switzerland
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