Design Engineering Lead

About GXP Consulting Switzerland

GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.

In order to continue to successfully support our clients, we are currently looking for a Design Engineering Lead:

Key Responsibilities

• Lead design & optimization of Fill & Finish aseptic processes (VHP, sterile filtration, aseptic transfers)
• Develop and review engineering documentation (URS, Functional & Technical Specifications)
• Coordinate with vendors and suppliers to ensure design requirements are met
• Review and approve PFDs, P&IDs, layouts, and engineering drawings
• Perform and validate engineering calculations and design assumptions
• Support equipment selection, procurement, and technical alignment with suppliers
• Participate in FAT and SAT to ensure systems meet specifications
• Collaborate with cross-functional teams (Production, QA, Validation, etc.)
• Ensure documentation is accurate and maintained in line with change control processes
• Contribute to project execution from concept through implementation
• Provide technical support during commissioning and start-up phases

Profile Requirements

• Degree in Engineering (Chemical, Mechanical, or related field)
• 7–10 years in pharma/biotech, with strong Fill & Finish aseptic experience
• Strong knowledge of engineering documentation (URS, FS, TS, PFDs, P&IDs, layouts)
• Strong knowledge of EU GMP Annex 1 and cGMP requirements
• Experience working with equipment suppliers and external partners
• Familiar with project execution phases (design, procurement, FAT/SAT, commissioning)
• Strong analytical and problem-solving skills
• Good communication and stakeholder coordination abilities
• Ability to work both independently and within project teams
• Fluent in German (spoken and written)

About us:

• Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
• We do care about our people, communicate openly and value feedback
• Work as a team where every member is valued and appreciated
• Opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
• Continuous learning and development opportunities via internal or external training and workshops
• Competitive salary package in line with industry practice together with exceptional employment benefits

At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!

If you also share the same passion and values, we will be glad to hear from you!