BioProcess Engineer

BioProcess Engineer
The Process Engineer 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 engineer participates actively in all areas of production where trained/certified to carry out the tasks, working independently as well as part of a team. The role also actively participate in continous optimisation and validation of existing and new processes and production equipment. Responsible for delegated areas within the overall responsibility of department.
RESPONSIBILITES
Main tasks
· Performing production of recombinant proteins according to written procedures for which training/ certification has been received.
o LN process and CAP process
o upstream and downstream operations, media and buffer preparations
o equipment handling and cleaning,
o materials handling
o production and facility support
· Documentation of activities according to QMS by recording events in for example BPRs, log-books, stock cards as well as reporting of unexpected events in HSE reports, deviations reports.
· Identify/perform/coordinate deviations investigations and Change Controls.
· Identify/perform/coordinate CAPA activities related to deviations, inspections and claims.
· Update/write SOPs and BPRs.
· Identify/plan/perform/report process optimisation activities of existing processes.
· Participate/plan/perform/report studies validation and qualification work.
· Contribute in process development (NPI/LCM) projects; scaling up, implementation and validation in collaboration with other team members and the process development team.
· Hold specific responsibilities to manage production system as outlined below.
· Act as SME (Subject Matter Expert) on own specific responsibilities areas.
· Perform training and supervision of new staff on own specific responsibilities areas and execution of production operations where own training is complete.
· Hold specific responsibilities e.g., responsibility of Equiptment according to Equiptment list, responsibility of Cheemicals & MSDS, and FMS on-call responsibility.


REQUIREMENTS
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 also from downstream processing is an advantage but not 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 (minimum 3yrs) 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.
HOW TO APPLY
Send your application, including CV and Cover Letter, to career@biolamina.com
Placement from earliest August, with reservation of withdrawal depending on forthcoming decisions and planning.
ABOUT BIOLAMINA
BioLamina AB is a Swedish based Biotech company that originates from scientific innovations at Karolinska Institute. Our main products are recombinant laminins, human proteins that are being used to maintain and expand pluripotent stem cells and other primary cell types and for subsequent differentiation into different specialized cell types. BioLamina is revolutionizing cell culture and our products are being used by researchers to develop cellular therapies, building on the era of regenerative medicine. Founded in 2009, BioLamina has grown organically and today we are about 45 employees who develop, produce, market, and sell cell culture research reagents to academic and industrial scientists globally. For more information, please see: http://www.biolamina.com
At BioLamina we are striving to work according to GMP within a few years. The company has a certified quality system according to ISO 9001:2015..
BioLamina is a member of IKEM – Innovation and Chemical Industries in Sweden. IKEM has collective agreements with relevant trade unions of the sector, and as a member Biolamina is fulfilling terms of employment according to collective agreement.