Process Engineer (f/m/d) 100 %. Visp, CH
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
Process Engineer (f/m/d) 100 %
My main tasks will be…
- Support and execution of facility and process setup activities for SER-109 process to ensure successful transfer into the manufacturing plants according to overall project timelines
- Setup and maintenance of GMP process transfer documentation and risk assessments
- Deliver process know-how, scientific expertise as well as operational excellence into LBP-production and continuous improvement
- Perform manufacturing activities according to cGMP guidelines
- Responsible to establish timely and with high quality the required production documentation (e.g. Batch Record Review, Deviation Reports, Risk Assessments, Changes)
- Executes trouble shooting, deviation- and change-management. Anticipate, respond and permanently resolve issues that arise during production. Will consult and work with SMEs from other departments
- Support Operations Manager in training and planning tasks
- Contribution to the development and implementation of standardized Manufacturing procedures and processes
- Driving continuous improvements in performing and ensuring alignment to current industry guidance and practices
- Represents Manufacturing during regulatory inspections and customer audits as SME
- Responsible to follow SHE standards and rules
- Works closely with MSAT department and Quality organization. Ensures a good information exchange and issue escalation throughout all organizational levels and functions
- Live and contribute to the Bacthera culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside the own area of responsibility
I bring with me…
- Educated to a degree level in a biotechnology, biochemistry, biochemical engineering, pharmaceutical science or similar discipline with 5+ years’ experience in Pharma environment, in Drug Substance or Drug Product Manufacturing
- Experience with troubleshooting manufacturing processes and industrial scale equipment.
- Experience working in a cGMP environment
- Strong written and verbal communication skills
- Excellent English language skills – German would be beneficial
- An organized individual with the ability to plan, rack and prioritize and adhere to project deadlines
- Ability to give presentations, scribe scientifically/technically and communicate both verbally and written
- Person that can learn quickly and is keen to broaden his or her knowledge
- Enthusiastic team player
My reasons for choosing Bacthera…
- Innovative and fast-growing start-up company with short decision-making processes
- Motivated, agile and multinational team
- Very good pension fund and attractive salary
- Fringe benefits (e.g., lunch card, deduction at different stores (such as Adidas, Samsung), 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 hear more about you.
Please send all your documents (motivation letter, CV, letter of references, diplomas, etc.) to Ms. Sandra Gamboni, Global Head of HR, email@example.com.
We are looking forward to your application!