Automation (PCS/EMS) Commissionning & Qualification Engineer

Lieu: Lausanne, Switzerland
Salaire: competitive
Type d'emploi: Mission Freelance
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Duration: 8 months (Start 1st January)

Location: Lausanne Area

Summary

Our client is building a large scale API bio-manufacturing facility (greenfield project).

The candidate will support all qualification and validation activities of automated systems: Process Control System (PCS) and Environmental Monitoring System (EMS) of biopharmaceutical drug substance manufacturing according to quality policies, cGMP, Swiss, EU / US FDA Regulations.

Duties and Responsibilities

  • Act as C&Q project manager for Process Control System (PCS) and Environmental Monitoring System (EMS)
  • Work with the project team, the engineering companies and the supplier (Rockwell) on the detailed design deliverable concerning PCS/EMS systems requirements
  • Review and approve the relevant design documentation (URS, FDS, HDS, SDS)
  • Lead the risk assessment exercises (FMECA), the design qualification and the traceability matrix concerning PCS/EMS systems
  • Review, customize and approve systems related documentation (suppliers FAT/SAT protocols and reports, IQ/OQ Qualification protocols and reports, deviations and change controls) to ensure compliance with cGMP and applicable regulations
  • Support the Commissioning & Qualification activities (test execution or test witnessing)
  • Perform quality audits for computerised and automated systems suppliers if needed
  • At all times work in view of the site readiness for regulatory inspections (Swissmedic and International)
  • Contribute positively to a strong culture of business integrity and ethics
  • Act within compliance and legal requirements as well as within company guidelines

Qualifications:

  • Must speak English and French (Native French is an advantage)
  • Must have minimum of 10 years in an automation engineering role in a biopharmaceutical manufacturing environment
  • Thorough knowledge of biotechnological technologies, processes, with a demonstrated experience in computerised and automated systems (PCS/EMS).
  • Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation
  • Must have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems
  • The ability to make pragmatic and compliant decisions
  • Strong result orientation and committed team member
  • Flexibility and ability to travel
  • Excellent written and verbal communication skills.

Education:

  • Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing, Automation or engineering
  • Advanced degree preferred

If you are interested to apply, please contact me at

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

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