Validation Engineer a Solothurn

pubblicato
contatti
Benoit Rochat, Basilea Professionals Health Care & Life Sciences
tipologia
Determinato
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specifiche della posizione

pubblicato
luogo di lavoro
Solothurn, Soletta
settore
Life Sciences
tipologia
Determinato
riferimento
15793
contatti
Benoit Rochat, Basilea Professionals Health Care & Life Sciences
telefono
058 201 54 40

descrizione

Are you an engineer with significant qualification and validation experience in the biotech/biopharma industry ? Are you willing to join one of the principal actors in the industry ? You should then read the following lines!

One of our clients, a renowned biotech company based in the Solothurn area, is looking for its next validation engineer for a mission until October 2021 (for now).

Tasks:

  • Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation

  • Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation

  • Management and coordination of validation activities with internal departments, external contractors and suppliers

  • Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities

  • Primary point of contact for validation related issues arising during validation activities (including protocol execution)

  • Investigation of deviations / non-conformances to determine impact on product quality, validation status and associated compliance requirements

  • Partners with functional departments to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA)

  • Performance of risk and impact assessments associated with validation activities, deviations and changes

  • Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required)

  • Performs final review of test data / reports to ensure conformance with established specifications and related standard operating procedures

  • Provide guidance on validation requirements and expectations to validation engineers and project team

  • Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution)

  • Represent the validation program and designated validation activities during inspection by regulatory agencies and company’s Quality / Regulatory functions

  • Review of technical documents / reports to ensure that validation activities are consistent with current company, industry and regulatory requirements

Profile:

  • 2+ years of experience in a Validation Role in a biopharmaceutical manufacturing environment

  • Large scale green/brown field project experience is a must

  • Thorough knowledge of biotechnological technologies, processes, and equipment

  • Demonstrated proficiency in Good Practice requirements (GMP, GEP) as well as biopharmaceutical industry regulations norms as they relate to validation

  • Strong technical writing and communication skills in English

  • The ability to take pragmatic and compliant decisions

  • Proficiency in MS Word, MS Excel

  • Experience working with Electronic Validation Document systems is highly desirable

 

Do you feel at home reading those lines ? Then do not waste a second and apply now!