Commissioning & Qualification Engineer

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Expert reconnu dans les métiers des Processus Industriels et en installations générales, ADEQUATE SWISS accompagne ses clients, majoritairement grands comptes, dans la réussite de leurs projets.

Nos équipes interviennent sur les fonctions Bureau d'Etudes, de chefs de projets, d'ingénieurs process, dans les domaines de l’industrie pharmaceutique, l’énergie, les traitements d’eau et de déchets.

Dans le cadre de notre croissance, nous vous proposons d'ouvrir vos perspectives de carrière en rejoignant ADEQUATE SWISS, entreprise innovante, dynamique et humaine.

Performs cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with ADEQUATE’ clients. Follows ADEQUATE and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non FDA regulated clients.

Detailed responsibilities:

  • Perform field/site activities (in the DACH region) including, but not limited to, the following:
  • Attend and witness FATs and SATs as a representative of ADEQUATE clients.
  • Execution of commissioning forms and witnessing of vendor start-up and testing.
  • Witnessing of vendor start-up and testing
  • Walk down and verification of system drawings (P&IDs, as-built, etc.).
  • Execution of C/Q/V protocols.
  • Review Commissioning documents (Fat, SAT protocols etc.) for GMP and Client suitability.
  • Write and support writing of C/Q/V documents following established standards and templates, including but not limited to the following: – C/Q/V Master Plans – Commissioning Forms – FATs/SATs – C/Q/V Protocols and Summary Reports – Impact Assessments – Specifications (URS/FRS/DDS) – Standard operation procedures
  • Planning/scheduling of C&Q activities
  • Support, train and provide guidance to engineers in the delivery of C/Q/V services and areas of expertise.
  • Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
  • Responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical and biotech industries.
  • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
  • Audit project deliverables to assure compliance with established standards. Review work of assigned project team.
  • Read and understand the ADEQUATE Best Practices and SOPs for delivery of compliance services.
  • Perform work to meet ADEQUATE budget requirements and quality standards. Provide consistent, complete and timely feedback and reports to ADEQUATE project leaders, project managers or management of project status and issues.
  • Maintain professional conduct and deliver services in a professional and acceptable fashion.

Qualifications: 

  • Bachelor of Science in Engineering or in a related field. Non-BS degrees will be evaluated on a case by case basis.
  • 3-4 years of experience in Pharmaceutical, Biotech, Commissioning, Validation. Experience in the writing and execution of PFC, FC, IQ, OQ and PQ forms and protocols for GMP Utilities, Equipment, Systems and Software is a plus.
  • Strong cGMP understanding and knowledge.
  • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
  • Language requirements: English is a must, knowledge in French is a requirement and German is a plus.

Référence de l'annonce : 19/10/2018/001

Secteur d'activité :

Salaire : 90 to 120 Kchf

Langue(s) : ,

Niveau écrit : (/5)

Niveau oral : (/5)

Pays :


Contact :

Matthieu MOYSES se fera un plaisir de vous fournir des renseignements complémentaires par téléphone au 0041 78 835 05 91.
Prêt-e à relever le défi ? Postulez sans plus attendre en envoyant votre CV à l'adresse suivante : matthieu.moyses@adequate-swiss.ch

Référence de l'annonce à rappeler lors de votre prise de contact : 19/10/2018/001