Sterile Manufacturing Specialist

Sterile Manufacturing Specialist


Competitive Salary & Benefits

Do you have experience of working within a GMP sterile environment? If so, this may be the opportunity you are looking for!

About AstraZeneca

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.

You could join a technical team with responsibilities for process robustness and continuous improvement associated with aseptically prepared and terminally sterilised products and associated APIs, manufactured at Macclesfield.

You’ll interface across departments to support and lead improvement projects to deliver enhanced sterility assurance. By ensuring that manufacturing operations meet all the current regulatory, compliance and AstraZeneca standards and you will actively handle risk.

We’ll expect you to ensure that these aspects are in place and you’ll be confident in discussing any related activities during Regulatory Authority inspections.

What you’ll do

You will be involved in evaluating and assessing technical issues to aid the resolution of quality incidents associated with the sterility assurance of products.

Providing aseptic expertise and resource to your local business area, you’ll develop strong relationships with the Sterile Manufacturing Specialist, Production, Microbiology, Technical Engineering and Quality functions. This will enable timely progression and resolution of issues positively and in the best interest of AstraZeneca.

With your hardworking approach you’ll be fundamental in identifying and delivering sterile product related technologies and best industry practices to your technical team and wider business area. This will involve proactively looking for opportunities to improve processes and procedures to improve compliance.

With strong network skills and ambition you’ll maintain and improve your own areas of technical competence and expertise. This will then assist you in providing initial and ongoing training and guidance on standard methodologies for ongoing aseptic security at AstraZeneca’s Macclesfield campus.

Essential requirements:

  • A scientific/technical degree or equivalent and experience of working in a GMP sterile environment
  • Confirmed experience of project delivery in a sterile manufacturing environment.
  • Experience in clean room technologies, sterile manufacture, sterilisation and basic microbiology
  • Good working knowledge of “Annex 1 Manufacture of Sterile Medicinal Products”, FDA “Sterile Drug Products Produced by Aseptic Processing” and ISO 14644
  • Ability to make complicated judgements within general operating guidelines and a systematic approach to problem solving
  • Excellent planning and interpersonal skills
  • Excellent verbal and written communication at all levels and effective influencing skills to build positive relationships with customers.
  • Ideally, you’ll have exposure of working within multiple aseptic or sterile manufacturing facilities, however this is not essential.

Why AstraZeneca?

At AstraZeneca, we ‘re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

If you are interested, then apply today!

Where can I find out more?

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