BioLamina is looking for motivated and experienced BioProcess Engineers for our two production sites. If you are looking for a position in a fast-paced biotechnology industry, we are inviting you to apply.

You will be part of the Production team, producing human recombinant laminins that are supplied to customers to support culturing platforms for different types of primary cells. To meet ISO 9001 and QMS criteria, the manufacturing is carried out in compliance with defined processes, established procedures, and relevant laws and regulations.

As BioProcess Engineer, you will play a crucial role in the delivery of product to customer, maintaining the quality system, actively contributing to continuous optimization and qualification/verification of existing and new processes and production equipment.

Main tasks and responsibilities

The BioProcess Engineer participates and contributes to the manufacturing of high-quality recombinant proteins according to defined processes. The Engineer will participate in a variety of production duties working both independently and cooperatively within the team and as part of cross functional teams:

• Production of recombinant proteins according to written procedures: Adherent and suspension cell processes, upstream/midstream operations, media preparations, equipment handling and cleaning, material handling.

• Documentation of activities according to QMS by recording events in, for example, BPRs and logbooks, as well as reporting of unexpected events in applicable reports.

• Identify and perform deviation investigations, risk assessments, Corrective and Preventive Actions (CAPA) and Change Control activities.

• Update Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).

• Contributing to continuous improvements of processes and procedures.

• Perform studies, qualifications and verifications.

• Responsibility of equipment

Qualifications

• Bachelor’s degree in science, technology, or biochemistry.

• A minimum of 1 year work experience as a Process Engineer in the chemical, biotech, or pharmaceutical industry.

• Experience with cell culture (Adherent and/or suspension cell processes, production of recombinant proteins).

• Experience in working within a quality system

o Deviation handling, Corrective and Preventive Actions (CAPA), Change Control activities.

o Standard Operating Procedures (SOPs) and Batch Production Records (BPRs); updating, writing, and improving

o Validation and qualification studies; planning, performing, and reporting.

• Experience in identifying, planning, performing, and reporting process optimization activities.

• Proficiency in Word and Excel.

• Proficiency in written and spoken English. Effective communication skills.

Merit if you have

• Aseptic working techniques and cleanroom practices.

• Experience of large-scale production process.

• Experience in chromatographic purification.

• Experience of working according to ISO 9001 and/or GMP.

• Swedish language.

Personal Skills

You have drive, and a goal-oriented and analytical mindset with good detail orientation. You manage a range of tasks and work environments with flexibility and adaptation. Likewise, you also possess great teamwork and communication skills. You approach your work logically and systematically while demonstrating independence and taking responsibility.