Process and Validation Engineers, AstraZeneca Global Operations, Sweden Biologics   

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together with the outmost integrity to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

The Sweden Biomanufacturing Center (SBC)  is a strategic investment to support the AstraZeneca biologic product portfolio. The new Drug Product manufacturing facility will have the capability to support the Astra Zeneca biologic commercial pipeline and biologic clinical trial and launch programmes. At Sweden Biologics we shape the future by delivering advanced and sustainable biological drugs. We operate in a multicultural and global environment where revolutionary digital solutions propel us forward.

Do you want to go to a job that makes a difference for both its employees, patients, and the planet?

We now offer an exciting opportunity for Process and Validation Engineers and also Senior roles of the same to join our new biologics manufacturing plant located in Södertälje, Sweden.

Your arena

Validation in the Manufacturing organisation is the function that supports and leads the work for initial Commissioning, Qualification and Validation activities and has the responsibility for assurance of maintaining the validated status.

Validation is supporting Manufacturing as well as areas of QC, Warehouse, Facilities and Utilities and Computerized systems.

We work sustainably for each other and the planet in a high-tech and positive LEAN environment. Coaching leadership and curiosity drive us towards finding new ways to make drugs that change lives.

The work is independent, varied and is conducted in close collaboration with other functions within the company. You report to the Site Validation lead and belong to a group of about 10 internal engineers and 20 external resources.

Your role

You will act cross-functionally and will be a point of contact for a one or several areas and projects. You will act with a quality champion mind set and have ability for a high level understanding and what it takes in details.

The Process / Validation Engineer will be responsible for:

• Design, creation, execution, evaluation and reporting of equipment qualification and validation
• Deviation investigation with provision of technical support including investigation, correction and prevention of issues
• Act as sub lead for Technology Transfers/New Product Introductions or other Capital or Improvement projects
• Communicate proactively with peers and stakeholders to highlight issues and propose solutions
• Collaboration with local quality, manufacturing, engineering and automation functions to develop and improve manufacturing and validation processes
• Act as Subject Matter Experts in internal and external audits

Essential Requirements

• Bachelor’s Degree in Science or Engineering
• Minimum 3 years’ experience of working with validation in a GMP environment
• Strong written and verbal communication skills in both English and Swedish with excellent technical writing capabilities
• Good knowledge of Drug Product equipment, facilities, engineering and instrumentation
• Knowledge in GMP manufacturing and validation regulatory guidelines
• Experience with specifying and validating process equipment, utilities, instrumentation and manufacturing processes

Desirable Requirements

• Important qualities are that you are structured, work for collaboration and communicate with your teams and functions. You have initiative, run your work independently and can lead cross-functional teams to achieve goals.
• Familiar and experienced with relevant systems and applications e.g. TrackWise,  Sharepoint, Workplace and Saba Cloud document management system.
• Knowledge in processes and validation for Formulation/Filling/Lyophilization/Assembly/Packing/Utilities.

Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines to our patients is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team in Södertälje? Good, because we can’t wait to hear from you and the description of your view of this role.

More information

For more information about the position please contact: Site Validation Lead Erik Dietrichson erik.dietrichson@astrazeneca.com

Welcome with your application with both a personal letter and a CV no later than September 23rd, 2021. Interviews will be held ongoing during the application period.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.