CSV Engineer

Proclinical are recruiting a CSV Engineer for a pharmaceutical organisation. This role is on a contract bass and is located in Visp. The client is focused on facilitating solutions that assist in preventing illness and assist people in having healthier lives.

Responsibilities:

• Produce the requested CSV documents rendering to the company's SOP's and regulations.
• Arrange the evaluations of the CSV documents till last QA approval.
• Contribute to the inspection as a company project CSV-representative.
• Outline with EMR and package units vendor the most suitable design for vertical integration within the company's setting.
• You will collaborate with process engineers, automation team (EMR), PM and QA.
• Serve as a subject matter expert on the company's CQV/CSV standards.
• The ideal candidate will serve as a CSV point of contact for the allocated system till the handover to the operation organisation.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Educated to a degree level in an engineering or applied science, though a post-graduate would be ideal.
• Familiarity within automation, as well as in vertical integration and data management under validated computer systems.
• At least 5+ years of commissioning, qualification and validation, which involves CSV with an acquaintance in managing multifaceted pharmaceutical projects.
• Prior involvement in biologics such as mammalian, CGT, as well as chemical manufacturing technologies.
• Familiarity working within a regulated pharmaceutical and/or engineering organisation with skills in planning CQV actions, guiding large senior reports and a comprehension of KPIs.
• Expertise on ISPE GAMP5 and ASTM regulations with acquaintance in large and multifaceted projects.
• Previous involvement in a management role within EMA/FDA regulated setting with know-how in present ICH, PIC/S, EU and US regulatory needs and their execution.
• Acquaintance within people management, both internally and externally, with respect to business aspects, training and development.
• Fluency in the English language with knowledge in German and another European language would be ideal.
• Able to think in an abstract manner.
• An agile individual with the ability to think analytically.
• Works well with others as well as independently.
• Capable of prioritising workload and implement tasks within a fast-paced setting.
• Communication skills both verbally and in writing.
• Able and willing to coach/assist colleagues.

If you are having difficulty in applying or if you have any questions, please contact Saulge Hubert at +41 61 508 70 73.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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