Process Engineer Fill & Finish

Exyte Switzerland AG; Basel; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Exyte Switzerland AG in Basel designs and delivers GMP-compliant facilities for aseptic filling, supporting pharmaceutical manufacturing projects from concept to handover.

We seek a Process Engineer Fill & Finish to contribute to facility layouts, process workflows, and procurement activities, ensuring regulatory compliance and project success across cross-functional teams and external partners.

Qualifikationen

• Bachelor's or master's degree in Pharmaceutical, Process, Mechanical or Life Sciences Engineering.
• Initial professional experience in pharmaceutical engineering or GMP environments.
• Strong GMP knowledge and regulatory awareness.
• Excellent communication and stakeholder management.
• Willingness to travel within Switzerland and internationally.

Aufgaben

• Take part in design and development of production facilities for aseptic filling operations (vials, syringes, and freeze-drying systems), from project initiation and conceptual design through detailed engineering, execution, qualification, and final handover.
• Drive the resolution of complex technical challenges related to facility layouts, process formulation areas, material and personnel flows, material handling systems, and supporting utility and auxiliary processes.
• Prepare and maintain GMP-compliant engineering documentation across all project phases, ensuring regulatory compliance and alignment with project requirements.
• Take ownership of project deliverables within your area of responsibility, managing scope, budget, schedule, quality, and technical procurement activities.
• Coordinate and manage cross-functional stakeholders and external suppliers throughout the project lifecycle, from RFP to FAT/SAT, commissioning, qualification and final handover.
• Ensure full compliance with GMP, quality, and regulatory standards, while promoting continuous improvement and industry best practices.

Kenntnisse

Communication skills

German & English (bilingual)

Project coordination

GMP awareness

Ausbildung

Bachelor's or master's degree in Pharmaceutical-, Process-, Mechanical-, Life Sciences-Engineering

Jobbeschreibung

Shape the future of pharmaceutical production with Exyte Switzerland.

As a leading engineering service provider to the pharmaceutical industry, we design and deliver cutting-edge, State-of-the-Art GMP-compliant facilities that enable innovative sterile manufacturing processes. Join our interdisciplinary team and play a key role in the planning and execution of complex plant projects. With your expertise, you will help develop innovative solutions, drive project success, and support our clients worldwide in delivering life-changing medicines.

Process Engineer Fill & Finish (m/f/d)

Explore your tasks and responsibilities

• Take part in design and development of production facilities for aseptic filling operations (vials, syringes, and freeze-drying systems), from project initiation and conceptual design through detailed engineering, execution, qualification, and final handover.
• Drive the resolution of complex technical challenges related to facility layouts, process formulation areas, material and personnel flows, material handling systems, and supporting utility and auxiliary processes.
• Prepare and maintain comprehensive GMP-compliant engineering documentation and technical specifications across all project phases, ensuring regulatory compliance and alignment with project requirements.
• Take ownership of project deliverables within your area of responsibility, managing scope, budget, schedule, quality, and technical procurement activities to achieve successful project outcomes.
• Coordinate and manage cross-functional stakeholders and external suppliers throughout the project lifecycle, from request for proposal (RFP) and contract award through FAT/SAT, commissioning, qualification and final project handover.
• Ensure full compliance with GMP, quality, and regulatory standards, while actively promoting continuous improvement, engineering excellence, and the implementation of industry best practices.

Show your expertise

• Bachelor's or master's degree in Pharmaceutical-, Process-, Mechanical-, Life Sciences-Engineering, or a related discipline.
• Initial professional experience in pharmaceutical engineering, facility design, project engineering, or pharmaceutical manufacturing within a GMP-regulated environment.
• Good understanding of GMP requirements, pharmaceutical regulations, and current industry standards, with the ability to apply them effectively in engineering and project activities.
• Strong communication, presentation, and stakeholder management skills, enabling effective collaboration across multidisciplinary teams and with external partners.
• Experience in project planning and execution, including project structuring, cost estimation and control, schedule management, and technical procurement processes.
• Willingness to travel within Switzerland and internationally as required. Excellent German and English skills, both written and spoken, are essential.