Principal Subject Matter Expert, Sterile Drug Product Processing – Global Operations

AstraZeneca; Södertälje kommun; On-site; SEK 600 000 - 800 000; Full time

Job summary

A leading pharmaceutical company in Sweden is seeking a Sterile Drug Product Processing Principal SME to lead critical drug product manufacturing projects. The ideal candidate will have extensive experience in sterile processes, expertise in GMP compliance, and the ability to manage complex project lifecycles. Join us in making a significant impact in the pharmaceutical industry and contribute to our mission of delivering medicines to patients faster and more affordably.

Qualifications

• 10+ years’ experience in Sterile Drug Product Manufacturing operations.
• In-depth knowledge of Sterile DP Manufacturing equipment and material transfer.
• Proven experience in the commissioning of equipment in GMP environments.

Responsibilities

• Lead specification, design, supplier selection, and delivery of critical projects.
• Collaborate with stakeholders to ensure compliance with SHE and GMP standards.
• Support projects across Europe and AsiaPac regions.

Skills

Sterile Drug Product Manufacturing

Process Engineering

Capital Project Delivery

GMP Compliance

Lean Manufacturing

Six Sigma Green Belt

Fluent English Communication

Education

Bachelor’s degree in Engineering

Job description

Are you ready to be the technical point of reference for sterile drug product manufacturing projects? As our Sterile Drug Product (DP) Processing Principal SME, you'll be responsible for the selection, design, and startup of GMP process equipment/systems. Based in Sweden, you'll support projects across Europe and AsiaPac regions. This is your chance to build a long‑term career with global knowledge and opportunities!

Your role

Join us as and become a pivotal force in shaping the future of our technical drug product packages. In this multifaceted role, you will lead with innovation and strategic vision to guide the specification, design, supplier selection, and successful delivery of critical projects. Your expertise in process engineering will be instrumental throughout the project lifecycle, ensuring seamless start‑up and optimal early operations.

Collaborate with key stakeholders at AstraZeneca to capture essential insights and ensure our designs not only meet but exceed SHE and GMP compliance standards. Embrace this opportunity to drive excellence and make a significant impact in the pharmaceutical industry.

Essentials for the role

• Principal SME: Bachelor’s degree (or equivalent) in Engineering with 10 or more years’ experience in Sterile Drug Product (DP) Manufacturing operations or process design and installation
• In‑depth technical knowledge of Sterile DP Manufacturing equipment, material transfer, and containment/isolation
• Proven Experience in the specification, procurement, installation, start up and commissioning of equipment in a licensed GMP pharmaceutical commercial plant
• Ability to interact with a wide range of internal business partners and leaders
• Strong experience with capital project delivery; from business case development through project execution and current GMP regulations
• Fluent communicator (written and verbal) in English

• Lean Manufacturing certification or Six Sigma Green Belt
• Combination Product Experience

Why AstraZeneca

At AstraZeneca, we're driven by our commitment to deliver accelerated growth and to make people's lives better. We're always working towards our ambition to deliver more medicines to patients quicker and more affordably. We're leading the way in delivering Lean processes that drive greater efficiency and speed. Sustainable practices are at the heart of what we do, ensuring we manage our environmental impact across all our activities and products. If you have the passion and the drive to accelerate growth and make people's lives better, then this is the place for you.

Ready to make a positive impact in a team where it means more, excellent - welcome with your application no later then November 24th.

Date Posted

14-nov.-2025

Closing Date

24-nov.-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.