Project Qualification Engineer (Pharma Engineering Solids)

The Drug Product Qualification department is looking for a Qualification Expert for independent operations engineering activities and project work in the Drug Product area in Basel and Kaiseraugst.

The production facilities consist of the following machines and systems:

• Filling machines (Liquid/Solids), encapsulation, tableting, granulation, labeling machines, inspection machines, assembly lines for syringes & autoinjectors, equipment washing machines, autoclaves, etc.
• Infrastructure systems: Cold rooms, cleanrooms, HVAC (heating, ventilation, air conditioning), compressed air, process air, WFI (Water for Injection) distribution, environmental monitoring, etc.

The Perfect Candidate:

Possesses a completed vocational training or a degree in fields such as automation, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology. Furthermore, a minimum of 5 years of professional experience in the qualification of automated pharmaceutical production equipment as well as sound knowledge of the GMP-regulated environment is required. Additional requirements include practical experience in implementing technical GMP specifications of regulatory authorities (Swissmedic, FDA, EMA) in investment projects and operations engineering. A structured, precise way of working as well as high social competence and the ability to communicate complex matters in a target-group-oriented manner are essential for this position. Very good German and English language skills are mandatory.

Tasks & Responsibilities:

• Execution and support of qualification activities in investment projects.
• Writing and executing qualification plans and reports.
• Reviewing supporting documentation for GMP compliance and fulfillment of acceptance criteria.
• Creating, tracking, and closing qualification action items/pendings.
• Maintaining inventory data of the qualified systems/equipment.
• Collaborative partnership with interface departments.
• Presenting qualification topics during inspections, answering inspection questions, and maintaining the contact person matrix.
• Assessing and evaluating the impact of changes and deviations on the qualified status and critical aspects.
• Carrying out (re-)qualification measures resulting from changes and deviations.
• Planning and conducting periodic qualification reviews.
• Approving technical planning documents.
• Assuming inventory responsibility.

Must-Haves:

• Completed education/training or degree in one of the following fields: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology, Biotechnology
• Min. 5 years of professional experience in the qualification of automated pharmaceutical production (Drug Product)
• Professional experience in a GMP-regulated working environment
• Neat, structured, and precise way of working.
• High social competence, ability to work in a team, and very good communication and coordination skills, including interaction with stakeholders at all levels.
• Openness and ability to actively contribute within a flat, agile organization.
• Practical experience in implementing technical GMP requirements of regulatory authorities (Swissmedic, FDA, EMA) in investment projects and operations engineering
• Focus on delivering results that make a valuable contribution to the business.
• Quick comprehension skills as well as the ability to break down complex issues and communicate them in appropriate language to customers or authorities.
• Autonomous and independent handling of complex tasks as well as reliable enforcement of agreed priorities.
• Very good German and English language skills are required.

Sounds interesting? Apply now – we’re looking forward to receiving your applications!

Application Submission Deadline: 20.07.2026