Automation (PCS/EMS) Commissionning & Qualification Engineer


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Recruiter

Real Staffing

Listed on

25th November 2019

Location

Lausanne

Salary/Rate

£83 - £84

Type

Contract

This job has now expired please search on the home page to find live IT Jobs.

Duration: 8 months (Start 1st January)Location: Lausanne Area SummaryOur 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 requirementsReview 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 systemsReview, 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 regulationsSupport the Commissioning & Qualification activities (test execution or test witnessing)Perform quality audits for computerised and automated systems suppliers if neededAt 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 ethicsAct within compliance and legal requirements as well as within company guidelinesQualifications: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 environmentThorough 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 validationMust have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systemsThe ability to make pragmatic and compliant decisionsStrong result orientation and committed team memberFlexibility and ability to travelExcellent written and verbal communication skills.Education:Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing, Automation or engineeringAdvanced degree preferredIf you are interested to apply, please contact me atSthree Switzerland is acting as an Employment Business in relation to this vacancy.

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