Process Engineer - Validation

At AstraZeneca, we unlock the power of What Science Can Do. Empowered to explore, every day we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases. Be part of the team where you are empowered to follow the science!

Pharmaceutical Sciences is accountable for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca's therapeutic areas.

Within Early Product Development and Manufacture (EPDM) in Gothenburg, Sweden, the manufacturing unit is accountable for delivering a vast portfolio of early investigational medicinal products. We have a wide range of manufacturing assets in three separate manufacturing facilities, supplying different types of clinical trial material to studies across the globe.

We are now looking for a skilled Scientist/Senior Scientist to join us at EPDM. The role will be located at our R&D site in Gothenburg, Sweden. With more than 3000 employees from over 70 different countries, our vibrant Gothenburg site is a truly inspiring place to work!



The role

Within the EPDM manufacturing unit, in the GMP (Good Manufacturing Practice) arena, you will make an important contribution in Validation/ Qualification equipment and /or facilities used to deliver development and manufacture of new medicines. This role revolves around the process of assuring right level of testing and associated GMP documentation to meet compliance of assets used in manufacturing of drug product. Listed activities below will have a significant impact on the speed, quality, and cost of the AZ development portfolio.

We expect the successful candidate to:

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Provide strong technical competence or willing to learn, credibility and ability to give assistance in direction and be part in delivery of qualification, periodic validation review, documentation, change management, and validation activities mainly connected to facility (HVAC, Media systems, Clean in Place etc.) and manufacturing equipment - all with GMP validated status.
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Provide solid contribution in project delivery and validation competence in facility refurbishment and installation of new equipment/ technology
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Excellent collaborate skills, working closely with internal and external partners ensuring compliance within the framework of GMP and SHE. In addition, an interest to be part of continuous improvement of capabilities improving our capacity and agility in manufacture
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Be a vital part of the validation network contributing to our GMP asset compliance. Upholding qualification standard as well as connected documentation key for our business. The role holder could participate in the preparation and provide documents and explanation concerning the processes for regulatory inspections at the Gothenburg site.
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Depending on previous experience, introduction and training in practical hands-on processes in our GMP facilities to understand GMP and compliance demands associated to validation of manufacturing assets.
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Be entrepreneurial and drive initiatives to further improve flexibility and productivity, bringing in and qualify new assets, resulting in shorter lead times or increased value for our customers and patients.



Experience/requirements

MSc in Engineering/ Pharmacy and/or extensive GMP-manufacturing experience from pharmaceutical/ clean room engineering is essential for this role.

We are looking for a scientist with excellent collaboration, communication, and planning skills with a strong sense of responsibility, teamwork and delivery focus. There is both scope and an expectation to build the range of accountabilities over time, in line with personal development.

Strong verbal and documentation skills in English is a requirement. We expect you to have a keen interest to learn and qualify complex manufacturing equipment and develop your expertise in validation. Experience from qualification of pharmaceutical assets or working in a manufacturing/ clean room or supply chain organisation and knowledge of cGMP is a merit for this role.



So, what's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you!



Welcome with your application (CV and cover letter) no later than 28 February.

We will review the applications continuously so please apply as soon as possible.



Additional information

Our Gothenburg site

Life in Gothenburg