Qualification and Maintenance Engineer Focus Process Equipment

Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

CREATE YOUR OWN FUTURE AS

Qualification and Maintenance Engineer Focus Process Equipment (f/m/d) 100%.

As Qualification and Maintenance Engineer with Focus on Process Equipment (Package Units) you ensure the needed availability and reliability of the process equipment for the LBP production by execute (or coordinate service suppliers) specific maintenance and calibration program. Define in collaboration with PU suppliers the overall plant maintenance strategy for MC4a (Visp Site) and represent the topic during customer and health authority inspections in MC4a.

My main tasks will be…

• Define and maintain overall plant maintenance strategy for MC4a (in collaboration with PU suppliers)
• Execute and/or coordinate maintenance program to ensure availability and reliability of process equipment in MC4a
• Ensure cGMP planning and documentation of maintenance and technical change activities
• Oversee the technical documents for process equipment
• Assess and gain efficiency of process equipment on a routine base
• Represent area of responsibility at customer and health authority inspections
• Ensure Environmental, Hygiene and Safety, Standards for the technical equipment
• Be part of the technical project teams for improvement processes and give input to feasibility studies for new technologies / processes
• Be the contact for Authorities e.g. SVTI
• Support in monitor the assigned budget

I bring with me…

• Degree in relevant engineering or life science field
• A minimum of 5 years’ experience in the GMP regulated pharmaceutical industry, preferably in Engineering
• Experienced and comfortable with Health Authority GMP inspections (e.g. Swissmedic, US-FDA) and customer audits
• Strong leadership skills in a matrix / project organization
• Excellent collaboration and communication skills
• Open-minded for new ideas in a fast-changing environment
• Strong business understanding
• Proactive and solution-oriented team player
• Very good knowledge of written and spoken English, German would be an advantage

My reasons for choosing Bacthera…

• Innovative and fast-growing start-up company with short decision-making processes
• Flexible working hours (possibility of Home Office)
• Motivated, agile and multinational team
• Very good pension fund and attractive salary
• Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
• Interesting and diversified tasks

This is the opportunity to be part of a fast-growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to learning more about you.

Please send all your documents (motivation letter, CV, letter of references, diplomas, etc.) to Ms Céline Künzi, HR Business Partner hr@bacthera.com

I am looking forward to your application!

Céline Künzi
HR Business Partner