MedTech Technical Project Lead – GMP & Cleanroom

Congenius AG; Bern; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Development opportunities

Pleasant working atmosphere

Zusammenfassung

Congenius AG in Bern is seeking an experienced engineer to lead and execute technical projects within GMP regulated environments in MedTech. You will bridge production and project leadership, manage budgets and timelines, and contribute to process improvements in cleanroom manufacturing.

You will work in a small, flat-hierarchy company with flexible hours, attractive working conditions, and strong development opportunities. Fluency in English and German is required, and the Bern area is expected.

Qualifikationen

• Bachelor or Master’s degree in Engineering (Mechanical, Electrical, Process, Chemical, or equivalent).
• +5 years of experience in technical project execution within GMP and regulated environments (pharmaceutical, biotech, medical devices or life sciences).
• Strong understanding of cGMP, EU Annex 1, and engineering documentation.
• Experience in budget and project timeline planning, and problem solving.
• Hands-on GMP environment experience and authoring technical documents.
• Team player in interdisciplinary teams; capable of leadership when needed.
• Fluent in English and German; German required in writing and speaking.

Aufgaben

• Serve as liaison between production teams and project leadership to ensure alignment.
• Perform technical troubleshooting and coordinate across departments.
• Drive optimization and continuous improvement in cleanroom operations, environmental controls, and aseptic manufacturing.
• Develop and implement electronic systems for documenting cleanroom interventions (MES and deviation management).
• Apply Process FMEAs to identify and mitigate risks.
• Provide guidance to customers and suppliers, exercising indirect leadership.
• Be flexible to work in cleanrooms and during shutdowns to minimize disruption.

Kenntnisse

Project execution

Budget planning

Timeline planning

Problem solving

Interdisciplinary teamwork

Decision making

Fluent English

German language

GMP experience

Ausbildung

Bachelor or Master’s degree in Engineering

Tools

MES systems

Jobbeschreibung

Congenius AG in Bern is seeking an experienced engineer to lead and execute technical projects within GMP regulated environments in MedTech. You will bridge production and project leadership, manage budgets and timelines, and contribute to process improvements in cleanroom manufacturing.

You will work in a small, flat-hierarchy company with flexible hours, attractive working conditions, and strong development opportunities. Fluency in English and German is required, and the Bern area is expected.