Sterile Manufacturing Specialist
- Experience Level
- Experienced (non-manager)
Sterile Manufacturing Specialist
Open date: 26/05/2021
Closing date: Midnight on 16/06/2021
Would you like to apply your expertise, to the day to day running of our sterile manufacturing department. In a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Macclesfield is one of over 400 sites here at AstraZeneca, providing an excellent environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's important to us that you bring your full self to work every day.
A technical team with responsibilities for continuous improvement and process robustness primarily associated with aseptically prepared products and associated APIs manufactured at Macclesfield.
You'll collaborate with a broad spectrum of departments to lead or support improvement projects to deliver enhanced sterility assurance. You will be significantly involved in ensuring that the manufacturing operations meet all the current regulatory, compliance and AstraZeneca standards, and through this proactively assess any associated risks.
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
Providing aseptic expertise and resource to your local business area, you'll develop positive relationships within your team as well as Production, Microbiology, Technical Engineering and Quality functions. By using your knowledge and utilising your ability to work with other teams, the right person will be strongly involved in defining and influencing the aseptic Compliance Improvement Plan, contributing in the timely progression of projects in the best interest of AstraZeneca.
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 mentorship on standard methodologies for ongoing aseptic security at AstraZeneca's Macclesfield campus.
You will be involved in evaluating and assessing technical issues to aid the resolution of quality incidents associated with the sterility assurance of products.
- A scientific/technical degree or equivalent and experience of working in a GMP sterile environment.
- Confirmed experience of project delivery (via management or support) 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 detailed 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 an aseptic or sterile manufacturing facility.
There are some phenomenal employee benefits that AstraZeneca offer. AstraZeneca can offer you a competitive salary, private healthcare, a fantastic holiday allowance, phenomenal training and development opportunities, and much more.
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, ground-breaking cutting edge methods and bringing unexpected teams together.
Interested. Come and join our journey!
Where can I find out more?
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AstraZeneca takes sustainability seriously and promotes green commuting through shuttle buses from the local station to site, car sharing, electric hybrid charging points and ample free parking facilities for cars and bikes