CSV Engineer

For our client we are currently looking for a CSV Engineer for a temporary project.

Accountabilities & Duties:

80%

• Acting as subject matter expert (SME) on following CQV / CSV standards
• CSV person of contact of the assigned system till the handover to the operation organization
• Participate to the system impact assessment as CSV SME
• Define with EMR and Package Units vendor the most appropriate design for vertical integration
• Create the requested CSV documents according SOP’s and Guidelines
• Organize the reviews of the CSV documents till last QA approval
• Participate to the FAT & SAT
• Create the tests protocols and execute the tests
• Close collaboration with CSV Lead or CQV Lead

10%

• Responsible for ensuring that SGIE projects in are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with the continuous improvement vision.

5%

• Participate in inspection as Project CSV-representative

5%

• Deputizing

Candidate profile:

Education:

• Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred.

Experience:

• Significant experience in automation
• Extensive experience in vertical integration and data management under validated computer systems.
• Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable.
• Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs.
• 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.
• Experience in People Management (internal and external) with respect to organizational aspects, coaching and development.

Languages:

• Excellent command of English and proven knowledge in German necessary (read and write) and other desirable.

Quality and Attitude:

• Can think at an abstract level.
• Agility - Must be able to learn, understand and apply new CQV processes and tools.

Knowledge and 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.
• Experience at working both independently and in a team-oriented environment.
• Ability to effectively prioritize and execute tasks in a fast-paced environment.
• Strong written and oral communication skills.
• Willing and able to train/support colleagues