BioLamina´s Quality Department is looking for a Validation Lead. If you have previous experience and are looking for an operational, hands-on position in a Swedish biotech company, then we would love to hear from you.
BioLamina is a company that develops and produces premium laminins, proteins, used in cell therapy production research. We work in an international environment with global clients within research, biotech, and pharma. BioLamina is a fast expanding company with successful growth.
The Quality Department at BioLamina is responsible for establishing in-house quality procedures, standards, specifications, systems, and supporting other departments to ensure that the operations at BioLamina meet the outlined requirements. Currently, the quality management is performed according to the ISO 9001:2015 standard, with the plan of achieving a GMP level production on one of our product lines and GMP level QC analysis within a couple of years.
The role and responsibilities
The Validation Lead role at BioLamina is new, and you will be responsible for all validations and qualifications connected to our QC equipment and, in the future, also manufacturing equipment.
The role includes responsibilities in:
- Issuing validation and qualification documentation, such as master validation plans, qualification protocols (IQ/OQ/PQ)
- Acting as SME for validation and equipment qualification activities
- Supporting qualification approaches, together with instrument and method SME´s
- Establish risk assessment programs for qualifications and validations
- Leading risk assessments in qualification efforts, requalification efforts and changes
- Plan, execute and support qualification and requalification of equipment
- To be up-to-date with GMP, engineering and company standards
- Training new employees in equipment qualification, risk assessments and validation exercises
- Responsible for BioLamina being compliant with the company safety guidelines
- Tracking qualification/re-qualification activities
- Supporting improvement projects and re-validation activities
You must have:
- A bachelor´s degree in biotechnology engineering or equivalent
- Previous working experience as a Validation Lead or as a Qualification Engineer in a GMP certified environment
- Experience authoring SOP, validation plans, leading risk assessments
- Experience in validation of QC analytical equipment
- Excellent writing and communication skills in English (equivalent to CEFR C1 level or higher)
Merit if you have:
- A master's degree in biotechnology, engineering or equivalent
- Experience in leading small to medium capital projects
- Experience in qualification of biomolecule manufacturing and purification equipment, such as bioreactors, chromatography systems (ÄKTA)
- An initiative taker who is able to work independently
- Have a flexible approach and enjoy working in an expanding start-up environment
- A problem solver who is a great team player and communicator
- Organised and structurally minded
Working at BioLamina:
At BioLamina, you will be part of a dedicated and high-performing team committed to making a difference in the world through our innovative products. We believe in continuous learning and development, fostering a positive work environment, and ensuring the safety and well-being of our employees.
BioLamina is a learning organization, and we value competence sharing from each other and from the outside. We value our employees, and we are committed to ensuring that the work environment is pleasant, sustainable, and safe. We embrace diversity and inclusion in all aspects of our business. We pride ourselves in providing equity in the workplace, making sure people are given equal opportunities, equal pay, and are well accepted for their differences.
We offer good benefits and opportunities for professional development in an exciting industry. Our office is centrally located in Sundbyberg, Stockholm, with good connections to public transportation (subway, light railway, and commuter trains). The office building also offers indoor car parking options.
The company is a member of IKEM - Innovation and Chemical Industry in Sweden. IKEM has collective agreements with relevant trade unions in the industry and as a member, Biolamina fulfills employment conditions according to collective agreements.