Automation (PCS/EMS) Commissionning & Qualification Engineer
Duration: 8 months (Start 1st January)
Location: Lausanne Area
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
- 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.
- 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.