Equipment Engineer

Bern  ‐ Onsite
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Description

We are currently recruiting for a pharma / biotech role as „ Qualification and Validation Engineer" for a sub company of one of the biggest pharma firms in Switzerland, located in Bern.

Key Facts:

Start Date: January 2018

Length: minimum 6 months

Extension: possible

Workload: 100%

Ort: Bern

Remote: no

What makes that project attractive?
  • Interesting international environment
  • Modern utilities
  • Open minded colleagues
  • Easy reachable by public transport
  • High responsibility as „Qualification and Validation Engineer"


Debrief about the project:

The ideal candidate supports with the whole equipment renewal process, from the vendor selection stage, until the commissioning, validation and qualification of pharmaceutical related machinery.

Technical Requirements:
  • Compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function.
  • Co-ordinate, manage and support qualification aspects of technical projects associated with the full lifecycle of system specification, test/qualification, ongoing support, such as execution of appropriate event impact assessments, support of modifications within Pharma (parenteral & base), MD&D, Chemicals, Utilities, IM/IT and LAB
  • Deliver support to interdepartmental clients and witness the execution of critical qualification/ validation steps if required.
  • Contribute to scheduling of PQ activities.
  • Assure review for compliance and approval of all critical qualification deliverables/ documentation (QP, URS, IA, DQ, IQ, OQ, PQ, P&ID schemata & PM-Plans) as determined in system Qualification/ Validation Plans.
  • Assure formal communication of a completed system qualification to representative Quality Assurance department by means of a Qualification Summary Report (QSR)
  • For new equipment, assure the existence of full lifecycle qualification documents.
  • Assures archiving of all qualification documents
  • Liaise with vendors regarding specification data for equipment and identification of critical instrumentation and ensure internal calibration methods were satisfactory against process range requirements

Non-Technical Requirements:
  • Some flexibility in working hours is required
  • Must be able to work on multiple simultaneous tasks with limited supervision
  • Quick learner, motivated self-starter
  • Excellent customer service, interpersonal, communication and team collaboration skills
  • Able to follow change management for internal guidelines
  • Language proficiencies
  • English and (Swiss) German spoken and written, essential


Profile:
  • Higher degree as engineer or pharmacy technician.
  • Minimum 5 years of experience in pharmaceutical or medical device area.
  • Excellent knowledge of GMP requirements.
  • Fluent in German and English


Sounds interesting? Those are the next steps:

If the position sounds interesting, please contact us and send us your updated CV.

If you have any questions, please do not hesitate to contact me any time.

Looking forward to working with you.

Kind Regards

Kaja Blomberg



Tel :

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start date
01/2018
Duration
6 Monate
From
Real Staffing
Published at
23.12.2017
Project ID:
1475407
Contract type
Freelance
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