CSV Engineer

Background:

Supporting assigned project(s) in Visp as CSV-Engineer:

• Create the requested CSV documents according to the client’s SOPs.
• Execute the CSV tests.
• Support the CSV timelines with PM & CQV-Lead.
• Close interaction with Process Engineers, Automation Team (EMR), PM, and QA.

Responsibilities:

80%

• Acting as subject matter expert (SME) on following client’s CQV / CSV standards.
• CSV person of contact of the assigned system till the handover to the operation organization.
• Participate in the system impact assessment as CSV SME.
• Define with EMR and Package Units vendor the most appropriate design for vertical integration in the client’s environment.
• Create the requested CSV documents according to the client’s SOPs and Guidelines.
• Organize the reviews of the CSV documents till last QA approval.
• Participate in 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 Visp are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with client’s continuous improvement vision.

5%

• Participate in inspection as client’s Project CSV-representative.

5% Deputizing

Candidate Profile:

• Technical degree (bachelor level) in engineering or applied science, post-graduate qualification preferred.
• 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 including 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 environment 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.
• Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment.
• Language: Excellent command of English and proven knowledge in German necessary (read and write) and other desirable.
• 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.

The NRL Group connects global companies with the right people to bring engineering projects to life. Supporting contracting companies with energy transition plans and working with our clients to create a cleaner, greener future.

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