Qualification Engineer to BioLamina

About the position
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.

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 is today performed according to the ISO 9001:2015 standard, with the plan of achieving a GMP level production of some of our product lines in a couple of 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
You will be the qualification engineer and the validation leader and be responsible for assigned Qualification and Validation activities.

- Issue of Qualification Plans, Protocols and Reports and support different Equipment and Systems owners by providing
technical knowledge
- 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

- Establish Risk Assessment programs for Qualifications and Validations

- Participate and moderate Risk Analysis of equipment, systems and processes

- Issue and updating of SOPs for qualification and validation based on internal and external guidelines and standards

- Issue and updating of MVPs

- Supporting and facilitating in problem solving

- Supporting improvement projects and re-validation activities

- Supporting Deviation Management process and CAPA management process on site

- Issue, execution and updating of the Project Validation Master Plans with support from quality team members.

- Reviewing qualification reports from suppliers as well as perform complementary validations.

- To be up to date with GMP, Engineering and Company standards and effectively applying these standards at job

- Assist training new employees in equipment qualification, risk assessments and validation exercises

- Responsible for being compliant with the Company safety guidelines and must be capable of recognizing unsafe situations and
acting to be safe during job

- Tracking qualification/re-qualification activities and must be able to communicate adequately (verbally/writing) to all levels
within the organization

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 long experience from working in a GMP certified organization.
- You have the experience and expertise to evaluate processes and prioritize, in order to move towards a GMP certification in the most cost and time effective way.
- 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
· Have experience of qualifying complex systems such as bioreactors, autoclaves, depyrogenization cabinets, aseptic
filling lines/isolators.

Personal qualities:
- You are flexible and you like working in an expanding start up environment.
- 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 organisation
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.comBioLamina 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.