Validation Engineer
Validation Engineer
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1 Vacancy
Job Description
BioLamina is seeking a skilled Validation Engineer to become a vital part of our dynamic Technology and Operations Team. If you are meticulous experienced and competent in your work and you want to be part of an innovative and fastpaced environment we would like to hear from you!
We are at the forefront of revolutionizing cell culture with groundbreaking products that researchers around the world rely on to develop advanced cellular therapies. As we contribute to the era of regenerative medicine we are looking for individuals who share our passion for creating premium products that enhance lives globally.
The role will be primarily based in Sundbyberg with occasional work in Flemingsberg. The successful candidate will collaborate with teams at both locations to achieve our shared goals.
Main tasks and responsibilities:
The work is carried out within crossfunctional teams comprising R&D Production QA/QC and project managers fostering a highly collaborative skilled and engaged environment.
Responsible for ensuring that good validation practice and processes are followed and maintained.
Verify that equipment facilities systems processes and products function as intended and comply with relevant regulations and standards.
Plan conduct record and participate in investigations validations and activities including coordinating supplier qualification visits.
Support documentation processes in accordance with the companys quality management system.
Contribute to integration and knowledge sharing across various functions within the organization.
Education and requirements:
M.Sc. in Biotechnology Engineering or a related field.
At least 5 years of working experience in a similar role.
Strong expertise in equipment qualification and biotech manufacturing processes.
Proven experience with documentation in accordance with quality management systems.
Excellent written and verbal communication skills in Englishwith knowledge of Swedish being an advantage.
Knowledge in validation of computerized and digital data systems is desirable.
Personal skills:
A successful candidate will demonstrate an interest in technology with excellent written and verbal communication skills. Enthusiasm to take initiatives contribute to problemsolving and proactively work within crossfunctional teams is imperative. A depth of understanding for biotechnology manufacturing techniques and equipment combined with a refined attention to detail will prove highly valuable within the Technology team.
BioLamina:
At BioLamina youll be part of an international valuedriven organization working alongside dedicated and highperforming colleagues. We believe our products can change the world and we have high ambitions to do so. BioLamina is a learning organization and we do this 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 pride ourselves in providing an equal workspace making sure people are given equal opportunities equal pay and are well accepted for their differences. Furthermore we embrace diversity and inclusion in all aspects of our business.
BioLamina AB is a Swedish biotech company founded on scientific innovations at Karolinska Institutet. Our main products are recombinant laminins human proteins used to maintain and expand pluripotent stem cells and other primary cell types for subsequent differentiation into specialized cell types. BioLamina is revolutionizing cell culture and our products are used by researchers worldwide to develop cellular therapies and contribute to the era of regenerative medicine. For more information please visit:
Employment Type
Full Time
