Technical Project Manager cGMP Annex I (temp, 100%)

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 provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.

Your Responsibilities

• Serve as a key liaison between production teams and project leadership, ensuring clear communication and alignment.
• Perform technical troubleshooting and coordinate effectively across multiple departments.
• Drive optimization and continuous improvement within cleanroom operations, environmental controls, and aseptic manufacturing processes (including sterile filtration of medicinal products).
• Develop and implement electronic systems for documenting cleanroom interventions (e.g., MES and deviation management systems).
• Apply proven expertise in Process FMEAs to identify and mitigate risks.
• Provide guidance and consultation to customers and suppliers, exercising indirect leadership where appropriate.
• Demonstrate flexibility to work in cleanroom environments and during shutdown periods to minimize disruption to ongoing production.

Your Skills and Experience

• Bachelor or Master's degree in Engineering (Mechanical, Electrical, Process, Chemical, or equivalent)
• Professional background: +5 years of experience in technical project execution within GMP and regulated environments (pharmaceutical, biotech, medical devices or life sciences)
• Solid understanding of cGMP, EU Annex 1, and engineering documentation
• Strong experience in budget planning, project timeline planning, and problem solving
• Hands on working experience in GMP environment and authoring technical documents
• Team player who works efficiently and flexibly within interdisciplinary teams
• Decision maker, taking the lead where appropriate and necessary
• Fluent in English and German - written and spoken, German is a must
• You will work in the Bern area for an ambitious, dynamic small company in the medical technology sector
• You benefit from flexible working hours and an exciting and versatile field of activity
• You work in a company with a flat hierarchy, short decision-making processes
• You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
• You benefit from modern and attractive working conditions and development opportunities
• An attractive salary and very good social benefits round off the offer