BIOBJP00003881: Quality Assurance, Quality Engineering Associate


Control Quality
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Quality Assurance, Quality Engineering Associate

Location: Solothurn, Switz157573.138776erland
Initial duration: till end 2022, subject to extension

Job Overview: Responsible for Quality oversight to review and approval of validation and engineering life cycle documents (URS, FS, RTM, RA, DS, configuration spec, drawings etc.), test protocols, deviations, change controls, work orders and any technical documentation in the scope of Facilities, utilities, equipment and client Execution System (global and local computeriz157573.138776ed systems) to enable start up, commissioning and qualification of new Large Scale Manufacturing facility. Furthermore, advice the project groups as appropriate and be an active member of the groups where quality input is needed.

The holder of this position will be responsible for the following activities:

  • Ensure Equipment, utilities and facility design, build and qualification is successfully done according to current GMP and regulatory policies.
  • Review and approval of Qualification, Validation and Engineering documents during both project and operational phases of the site.
  • Involvement in validation and change control of the BES systems being implemented and operated at the Solothurn site.
  • Review of GMP documentation and data for compliance to applicable procedures, regulatory and/or corporate guidance documents.
  • Responsible for QA activities (Protocol deviations, test protocols, change control and QRMs) associated to equipment and automation systems in scope.

Other Posting Information – Information to be included in posting (as required) This position requires co-operation with people at every level of the organiz157573.138776ation and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.

Good communication skills in English, verbally and written. Technically orientated role including experience of the validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.

Self-driven and take ownership and responsibility for own assignments. Value teamwork at all levels, performs work with an open-mind and ability to value input from colleagues and peers. Able to drive discussion to solve problems with cross functional teams.

Be confident in making technical decisions. In addition, must be able to prioritiz157573.138776e tasks, be flexible and able to keep many activities running at a time.

Please note: only EU nationals will be considered for this position.

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