CQV DSP

Bern  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Beschreibung

CQV Engineer (all genders)

Duration: 1 year with possibility for extension

Location: Canton Bern

Remote: no / 100 % on site mandatory

For one of my Greenfield clients I am currently looking for a CQV engineer.

Main Responsibilities:
  • The position holder acts as technical engineering specialist supporting construction, commissioning, verification and qualification activities for downstream equipment within the bulk process project.
  • The position holder is responsible to ensure that the milestones for construction, commissioning, verification and qualification are met.


The position holder is also responsible for the review and preparation of GxP relevant documents

Technical Responsibilities:

Construction Support (Field Engineering Support)
  • Be the Engineering SME for the downstream processing area (Equipment & Overall Space) and support the construction team. Act as a link between, general planner and downstream equipment suppliers.
  • Respond to Requests for Information (RFI) from and Contractors. If a RFI results in a Change, track and coordinate the actions accordingly
  • Attend the Walk downs for Construction and Mechanical Completion
  • Support resolving issues that may arise in the field (clashes, etc.)CVQ & Automation Support
  • Review, comment and approve the relevant CVQ and Automation Documentation within the given timelines
  • Respond to Requests for Information (RFI) from CVQ and Automation contractors. If a RFI results in a Change, track and coordinate the actions accordingly
  • Preparation of qualification documents (e.g. RTM, DQ, IQ, OQ, etc.)
  • Attend equipment and software FATs as applicable
  • Attend and support on-site CVQ activities to assure safe, compliant and timely execution
  • Supervision of downstream processing equipment suppliers during CVQ phaseVendor Documentation
  • Review, comment and approve the VTOPs and CTOPs for the downstream packages as per the instructions and workflows General activities
  • Bears responsibility and accountability for working according to cGxP, health, safety and environmental requirements as laid out in the SOPs and procedures as well as all relevant external / governmental guidance.
  • Support construction/ commissioning/qualification teams to ensure that the mechanical completion, commissioning and IQ/OQ/PQ steps are achieved in line with the integrate schedule and support the startup of the equipment
  • Involvement in issue reporting, tracking and resolution and attending coordination meetings between the various disciplines to ensure smooth construction, commissioning, verification and qualification of the downstream processing equipment
  • Supports Lead DSP Equipment Engineering interfacing with others project stakeholders to assure overall coordination


Supports the Maintenance Groups in the definition of the maintenance systems and maintenance schedule

Education:

Degree (Dipl. lng., Bachelor, Masters or higher) in life science, mechanical, process or chemical engineering

Languages: English fluent in written and spoken, German and/or French are a plus.

Experience:
  • Min. 5 years of experiences in the life science, pharmaceutical or chemical industry as a project and/or C&Q engineer
  • Proven Experience and knowledge in biotech downstream processing
  • SIP and CIP knowledge
  • Experience with Process Control Systems (e.g. Siemens)
  • Understanding the needs for cGxP and CVQ


Competencies:
  • Technical expertise on biotech processes and hygienic design
  • Able to work with the required oversight to fulfill deliverables within target date
  • Approachable Team player with good communication skills
  • Proactive and solution oriented
  • Independent and exact working
  • Reliable and in-time delivery of results


If you are interested in this position please contact me on or give me a call on .

Looking forward to speaking to you.

Regards

Kaja

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
09/2019
Von
Real Staffing
Eingestellt
23.08.2019
Projekt-ID:
1814271
Vertragsart
Freiberuflich
Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
Registrieren