Vacancy Validation Engineer – Malmö
For a pharmaceutical company in Malmö, we are seeking an experienced Validation Engineer. The company has approximately 95 employees and is part of a Spanish pharmaceutical group. It is a versatile company that both develops, manufactures, and launches pharmaceutical products, medical devices, health supplements, and cosmetics. The products are for topical use such as lotion, ointments, and gels. The quality system follows GMP (Good Manufacturing Practice) and ISO 13485. The company is expanding with new production lines, so if you find this interesting and have the right qualifications please keep reading and don’t hesitate to apply.
Your job will be to qualify and validate new equipment as well as optimise the flow in existing product lines. You will identify these opportunities for optimisations together with the production team and the technicians. You will partly be a project manager for cross-organisational projects responsible for the equipment part of the products. The company is in the process of expanding the organisation so there is a great opportunity to exert influence in your role. The company also has an older product line that will be replaced where you need to take the lead on design, procurement, installation, and qualification. You will work with LEAN flow in different production processes, and you will develop and carry out training of production staff. Moreover, you will participate in production when commissioning new equipment and processes.
When the development department needs support for new products, you will participate in the projects and support the purchase of new equipment or the adaption of existing equipment and documentation. You will be responsible for qualification and re-qualification of equipment and periodic inspection of equipment. Other responsibilities include producing documents for URS/IQ/OQ/PQ NS, conducting change cases and writing SOP’s. You will also work with risk management, perform risk analysis and develop OEE analysis. Furthermore, you must work in a committed way with all kinds of tasks related to the production of medicines and your contact surfaces will be both internal and external. Finally, you will help with IT related issues regarding serialisation.
The right candidate ideally has the below mentioned competencies:
- Bachelor of Science in Engineering or higher
- 3+ years of work experience within the pharmaceutical industry/medical device with experience working according to GMP.
- Good knowledge of qualification, root cause investigations, and risk analysis and you have worked with different types of investigative work
- Experience with production in clean room environment
- Good knowledge and experience with writing technical documents
- Good IT skills and knowledge of Office Package
- Fluency in Swedish and good English skills are a requirement.
The organisation offers you:
- To work at a great, expanding company with wonderful colleagues
- Part of Swedish collective agreement
- 8 weeks of vacation
- Yearly wellness allowance
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Senior Consultant | Nordics
+45 89 88 26 70