Qualification Engineer to BioLamina

Qualification Engineer to BioLamina

BioLamina is looking to recruit a Qualification Engineer. You will be working with highly competent, friendly, and dedicated colleagues at a company that is continuing its successful growth. If this sounds interesting to you - come join us!

The role is full time and based in Sundbyberg, Sockholm, Sweden. We welcome your application today!


About the position
The Quality Department at BioLamina is responsible for establishing in-house quality procedures, standards, specifications, systems, and to support other departments to ensure that the operations at BioLamina meet outlined requirements. The Quality Management at BioLamina perform according to ISO 9001:2015 standard, with the plan of achieving GMP standard within three years.
BioLamina is currently constructing a new production site. In the roll as Qualification Engineer, you will be responsible for all validations connected to the new facility. This is a new roll and will be an operational, hands-on position. In time, this could evolve into a team of qualification coworkers.

Responsibilities
Leading assigned Qualifiction and Validation activities.
Planning and execution of the qualification of equipment and systems as well as validation of processes together with the equipment/process owner, supporting contractors and vendors.
Reviewing qualification reports from suppliers as well as perform complementary validations.
Issue of Qualification Plans, protocols and reports and support different equipment and systems owners.
Be writing SOPs and be responsible for the quality system regarding qualification and validation.

Your profile
Education:
You have a master in biotechnonolgy engineering or equivalent academic education.

Experience:
You have previously been working as a Qualification Engineer for several years.
You have been working in a GMP certified organization.
You also have experience in:
• validation of bioprocesses, such as ÄKTA chromatography systems, freezers, cell culture systems and incubators.
• GMP – both following SOPs and writing them.
• English, fluent with high vocabulary in both writing and speaking.
Merited if you:
• Have experience of qualifying complex systems such as bioreactors, autoclaves, depyrogenization cabinets, aseptic filling lines/isolators.

Personal qualities:
• You need to be flexible and work in an expanding start up environment.
• You also need to be able so see the details and prioritize, to move towards a GMP certification.
• You take initiatives and work independently
• You thrive when you get to create structure and organization from an innovative place.
• You are a problem solver who is a great team player and communicator.

About the organization
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

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.