QA Specialist, CSV & Automation

For our pharmaceutical client based in Visp
, we are currently seeking an experienced QA Specialist, CSV & Automation to support large-scale CAPEX projects within a GMP-regulated manufacturing environment.

The "QA Specialist, CSV & Automation" is responsible for the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment and utilities used in the GMP manufacturing of drug products as part of the Lonza CAPEX project portfolio in Stein, AG. The role covers the compliance of commissioning and qualification for large CAPEX projects (e.g. new drug product facilities) from ideation to execution phases, throughout all design phases.

• Ensures that qualification/validation plans and the execution of equipment, infrastructure, and computerized systems are in place, adhering to Lonza Quality policies.
• Approves SOPs, commissioning/qualification/validation protocols and reports, as well as project‑related CQV/CSV documents (e.g. URS, FAT/SAT, etc.).
• Provides QA leadership, oversight, and support to staff on qualification/validation topics related to ongoing projects; ensures that selected vendors are qualified.
• Acts as the first point of contact within GQE for any area related to the lifecycle and compliance of equipment, infrastructure, and computerized systems qualification/validation, including documentation in shared global systems (e.g. Kneat, Trackwise, DMS, Unifier, etc.).
• Manages Quality deviations, changes, and CAPAs/tasks in an open and timely manner, taking leadership for their resolution and escalating when necessary.

• Bachelor or Master's degree in Engineering, Life Sciences, or a related field.
• Significant experience in the GMP regulated pharmaceutical industry, preferably within a Quality Unit.
• Experience in a QA role for the CSV/Automation of GMP systems related to aseptic fill‑finish processes and facilities (filling equipment, lyophilization, clean utilities, and clean room facilities).
• Fluent in English;
  German is an advantage.