CQV Engineers- Process Equipment

Bern  ‐ Vor Ort
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Beschreibung

Upstream, downstream and Clean utilities system experts required for a major start up biotech project in Switzerland with a market leading organisation,
The Process Owners will be responsible for GMP equipment system engineering work packages during the design, construction and start-up of our client's new green-field, large scale manufacturing facility in Switzerland.
Equipment to include: bioreactors, vessels, cell harvest equipment on upstream ultrafiltration, diafiltration, chromatography on downstream Clean utility systems to include; clean steam, purified water etc.
  • Supporting the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new systems and equipment utilised in the production of biopharmaceutical drug substance.
  • The initial focus of this position will be to drive the commissioning and validation effort by developing plans, writing test protocols and hands on field execution of commissioning and validation within specific process areas (cell culture, purification, clean utility, etc.), including assistance training new manufacturing associates who will also support the commissioning and qualification activities.
  • Develop test plans and protocols for FAT, SAT, commissioning and validation. Lead commissioning within assigned areas, including equipment inspections, factory acceptance testing (FAT), site acceptance testing (SAT), field verification walk-downs and commissioning test execution. Provide equipment and system mechanical completion walk-downs, safety walk-downs, system energisation 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
  • Provide engineering input during design development, construction, testing, commissioning and validation, and help manage changes through the project. Review and approve engineering specifications, including piping & instrumentation diagrams (P&IDs), datasheets, and procurement packages for new equipment and systems. Review and approve equipment vendor submittals, including system piping layouts, general arrangements and other equipment specifications and drawings.
  • Provide coordination with other project stakeholders and suppliers. Interface with stakeholders to ensure the design, execution and delivery are aligned with stakeholder needs and expectations, and in accordance with Global Engineering, Quality, Environmental and Safety procedures.
Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management

Please apply now for these excellent, long term opportunities.
Start
ab sofort
Dauer
6 months initially
Von
Quanta Consultancy Services
Eingestellt
01.03.2017
Projekt-ID:
1296790
Vertragsart
Freiberuflich
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