Qualification Engineer (m/f/d) in Visp

veröffentlicht
Kontakt
Mari Slavova, Randstad Inhouse Services Lonza Visp
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Visp, Wallis
Sektor
Bau
Jobtyp
Temporär
Referenznummer
142523-1169
Kontakt
Mari Slavova, Randstad Inhouse Services Lonza Visp
Telefon
+41 61 316 25 42

Stellenbeschreibung

We are looking for a Qualification Engineer (m/f/d) for Lonza AG (100%). This is a temporary position until 31.08.2022.

Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there's no magic formula to how they do it. Their greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, they let their people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work Lonza wants to be part of.

In this role you will be the main point of contact of all arising questions around commissioning and qualification of process equipment and functionality requirements. This role works also in close liaison with the Operations team. Main role will be document preparation, review & approval coordination (DQ, IQ, OQ, GMP RA among others).

Key responsibilities

  • Prepare CQ lifecycle documents acc. to Lonza standards

  • Be the single point of contact and coordinate document reviews and approvals for one process step (Media Preparation, USP, REC or DSP)

  • Based on progress report of the CQ manager, perform on a regular basis field spot check follow-up

  • Communicate the day to day schedule to the Lonza technical lead, CQ manager and Operation leads.

  • Ensure a good communication with other Specialists linked to its activity (Battery limits)

  • Maintain his knowledge accuracy based on new technology. Keep up-to-date, report, escalate if necessary.

Qualifikation

  • 3+ year-experience in large scale EPCM (Engineering, Procurement and Construction Management) in the pharmaceutical industry

  • Bachelor, Master diploma or equivalent in biotechnology engineering

  • Strong background within manufacturing process equipment (USP, REC, DSP, MP) and its functionalities.

  • Comos knowledge preferable

  • Knowledge of electronic documents management system (Documentum D2) is a must

  • In-depth technical experience in a regulated environment with knowledge of biologicals, pharmaceutical and engineering operations

  • Good understanding of EHS (Environment, Health and Safety) and Quality aspects

  • Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant

  • Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.

  • Profound knowledge of USP/ DSP/ small and lab equipment technologies

  • English spoken and written mandatory, fluent German is advantageous

  • Willingness to work in an international environment