CSV Engineer

Job content

Tech’Firm Industrie AG is a Swiss engineering company with more than 20 years of experience and 300 dedicated engineers.

Our motto: Delivering with happiness!

We offer a friendly environment with trusting relationships. Our mission is to give meaning to the activities of everyone in the company.

We are hiring our next CSV Engineer:

• Create the requested CSV documents
• Execute the CSV test and support the CSV timelines with PM & CQV-Lead
• Close interaction with Process Engineers, Automation Team (EMR), PM and QA
• Forcing the QV/CSV approach during the entire project

Candidate profile:

Education: Technical degree (Bachelor) in engineering or applied science, post graduate qualification
preferred.

Experience:

• Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong
• experience in management of complex pharmaceutical projects With biologics (mammalian, CGT)
• Chemical manufacturing technologies desirable
• People Management (internal and external) with respect to organizational aspects, coaching and
• development.

Skills:

• Expertise in automation and vertical integration as well as data management under validated computer systems
• Versed with planning CQV activities, leading large senior reports and high
• understanding/management of KPIs in regulated pharmaceutical industry and/or engineering company
• Strong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects.
• Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.

Languages:Business fluency in English, German advantageous
General skills:

• Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment.
• Strong analytical skills. Ability to conduct in-depth analysis of complex/large data sets, draw
• conclusions accordingly, and prepare and support decisions.
• Ability to effectively prioritize and execute tasks in a fast-paced environment.
• Experience at working both independently and in a team-oriented environment.
• Strong written and oral communication skills.
• Willing and able to train/support colleagues.
• Ability to think abstract
• Agility - Must be able to learn, understand and apply new CQV processes and tools.

Job Types: Contract, Permanent