Role and responsibilities

The Process Operator is part of the Biolamina Production team, responsible for manufacturing (cell vial to finalised & labelled product in vials) of high-quality recombinant proteins according to defined processes (LN and CAP) according to written procedures to fulfill ISO 9001 QMS and applicable laws and regulations.

The process operator participates actively in all areas of production where trained/certified to carry out the tasks, working independently as well as part of a team. Responsible for delegated areas within the overall responsibility of department.

• Performing production of recombinant proteins according to written procedures for which training/ certification has been received. LN process and CAP process; upstream and downstream operations, media and buffer preparations; equipment handling and cleaning; materials handling; production and facility support
• Documentation of activities according to QMS by recording events in for example BPRs, logbooks, stock cards as well as reporting of unexpected events in applicable reports.
• Identify/Participate in deviations investigations, CAPA and Change Control activities.
• Update SOPs and BPRs.
• Hold specific responsibilities to manage production system e.g., responsibility of Equipment according to Equipment list and FMS on-call responsibility.

Qualifications and Education requirements

• Process operator, chemical industry –  1-2 years of experience
• The ideal candidate will have a laboratory science background and/or previous experience of working in the process industry with upstream processing, or equivalent qualification. Experience from downstream processing is an advantage but not a requirement.
• Experience of cell culturing is an advantage
• Experience in biotechnological production of recombinant proteins, aseptic working technique, cleanrooms is an advantage.
• Reliability, interpersonal skills and attention to detail are highly valued
• Bachelor’s degree within Science, technology, biochemistry is required
• Basic office computing skills – Word and Excel
• Working according to GMP it is an advantage but not a requirement.
• Good knowledge of English both spoken and in writing. Knowledge of Swedish is a plus.

In general:

• Adhere to relevant safety and quality standards, for process efficiency, product safety and operational safety.
• Report observations/ deviations within and outside delegated responsibility.
• Perform work in compliance with the BioLamina Quality Management System (QMS) and contribute to continuous development of the QMS.
• Keep own training and training documentation up to date.
• Plan and perform own work in accordance with department prioritisations and goals.
• Contribute to continuous development of company and department performance and smooth day- to -day running of the production and well-being of the team.

Is this you? Welcome with your application!