Downstream BioProcess Engineer

at  Biolamina AB

BioLamina is seeking a skilled and experienced Downstream Bioprocess Engineer to join our dynamic team. If you are excited about working in the fast-paced biotechnology industry and possess the relevant expertise, we would love to hear from you. As a Downstream BioProcess Engineer, you will play a key role in our production team, contributing to process optimization manufacturing of high-quality recombinant proteins.
At BioLamina, we are manufacturing high-quality recombinant proteins according to defined processes. This role involves adhering to written procedures to ensure compliance with ISO 9001 Quality Management System (QMS) and relevant laws and regulations. The role entitles you to work both independently and collaboratively within the team, participating in various production tasks and actively contributing to continuous process improvement and qualification efforts.
Main tasks and responsibilities:

The Downstream BioProcess Engineer will be focusing on the Downstream Processing and be a part of the Production team. The work is performed in cross-functional teams in a highly collaborative, competent, and engaged environment.

• Plan, organise, and execute the downstream production tasks, and producing the product in accordance with the production master plan to fulfil production requirements.
• Quality work in terms of batch record reviews; deviation handling; planning, performing and documenting studies; performing change controls and CAPAs.
• Act as the SME (Subject Matter Expert) in responsible area.
• In accordance with the requirements, write and update the SOPs and the batch protocol (BPR), logbooks and stock cards.
• Conduct data analysis, provide reports, and improve processes.
• Management of quality documents connected to the downstream process.
• Equipment responsibility.
• Contribute to integration and knowledge sharing between different disciplines and functions in the organization.

Education and requirements:

• Bachelor’s degree in Science, Technology, or Biochemistry.
• Up to 2 years of experience as a BioProcess Engineer in the chemical, biotech, or pharmaceutical industries.
• Extensive knowledge of downstream purification techniques such as chromatography (affinity, ion exchange, size exclusion), filtration (TFF, UF/DF), and centrifugation.
• Proficiency in identifying, performing, and coordinating deviation handling. Corrective and Preventive Actions (CC, CAPA) activities.
• Experienced in updating, writing, and improving Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
• Previous involvement in, preparation for, execution of, and reporting of qualification studies.
• Proven ability to identify, plan, perform, and report process optimization activities.
• Proficiency in Word and Excel.
• Excellent verbal and written communication abilities in English.

Merit if you have:

• Experience in biotechnological production of recombinant proteins, aseptic working techniques, and cleanroom practices.
• Handling experiences of large-scale production process.
• Proficiency in Äkta and other chromatographic systems.
• Experience in optimizing downstream protein purification processes.
• Familiar with cell culturing and bioreactor operation.
• Working according to GMP.
• The Swedish language.

Personal skills:
We are looking for someone who thrives in the optimization and scale-up processes of laboratory activity. You are good at noticing issues and finding solutions, and are meticulous and calm in your work. You possess strong independence and self-motivation and have a positive outlook on life and express an interest in the growth and viewpoints of your coworkers.
BioLamina
At BioLamina, you will be part of an international, values-driven organization where dedicated, high-performing colleagues collaborate to make a meaningful impact. We believe our products can change the world, and we have high ambitions to do so. BioLamina is a learning organization, and we do this from each other and from the outside. We value our employees, and we are committed to ensuring that the work environment is pleasant, sustainable, and safe.
We pride ourselves in providing an equal workspace, making sure people are given equal opportunities, equal pay, and are well accepted for their differences. We embrace diversity and inclusion in all aspects of our business.
BioLamina AB is a Swedish biotech company founded on scientific innovations at Karolinska Institutet. Our main products are recombinant laminins, human proteins used to maintain and expand pluripotent stem cells and other primary cell types for subsequent differentiation into specialized cell types. BioLamina is revolutionizing cell culture, and our products are used by researchers worldwide to develop cellular therapies and contribute to the era of regenerative medicine. For more information, please visit: http://www.biolamina.co

Please refer the Job description for details