Sterilisation Support Officer
Location: Cheshire East
Job Type: Full time
Sterilisation Support Officer
Location: Macclesfield, UK
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company 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 a high performing team, we are united and motivated by our shared purpose – to push the boundaries of science to deliver life-changing medicines. We come to work each day to make a difference – to patients, society, and our company.
Here you will experience a fast paced and agile environment as we continue to support the business on a journey of evolution and growth, driven by new, exciting technology and digital innovations. It’s challenging and sometimes demanding, and that’s why we love it.
The role holder will be a member of the Zoladex Technical team within UK Operations. The Zoladex group is part of the larger UK Ops function within the Operations organisation. The Zoladex Technical team has responsibilities for all aspects of sterile manufacturing process and continuous improvements across all the Sterile Pharmaceutical Plants at Macclesfield
The Sterilisation Support Officer (SSO) will be involve in sterilisation validations by planning, leading and execution of the schedule of sterilisation process qualifications (Moist Heat, Dry Heat and Radiation) and lead sterilisation related activities across the Zoladex and QA departments to meet all required levels of GMP compliance.
You will run a schedule of steriliser qualifications. This includes autoclaves, sterilising ovens and freeze dryers. On a periodic basis, the sterilisers undergo qualification testing in order to validate and verify that they are performing consistently. Your remit will be to ensure that this work is completed in a timely manner whilst minimising the loss of production time.
You will have Project Involvement by supporting new asset initial validations alongside the production of technical reports connected to sterilisation equipment.
You will join a developing and supportive team, receiving in house and external training.
We'll be looking for good verbal and written communication skills and effective networking skills. These will be required for clear and effective liaison with our supervisors/managers within production.
We require somebody with good numerate and literate skills with a detailed approach to problem solving.
High levels of concern for standards and attention to detail with a self-motivating and proactive approach are also required.
Ideally scientific/technical degree/Level 3 background is desirable or appropriate experience in aseptic production environment and relevant experience of steriliser operation.
Experience of working in a GMP environment.
Experience with the operation of sterilisers and sterilisation processes. (Including Moist Heat, Dry Heat and Radiation). This will include the application of current international standards and regulatory requirements for sterile product manufacture and steriliser qualifications.
Key Responsibilities :
To own a schedule of steriliser qualifications across various plants and departments.
Draft and obtain approval of qualification programmes, and the reports to meet the GMP/Regulatory standards.
Hands on - run qualification cycles by placing Biological indicators and Thermocouples, in predefined locations as per qualification programmes.
Working within a team to achieve operational delivery, within a complex and multidisciplinary production environment.
Lead the problem solving and correction of problems associated with sterilisation issues. You'll contribute to improving the efficiencies of the manufacturing operation.
Assist in the implementation of new equipment, systems and procedures. This will assist us in meeting growing demand from business and/or regulatory standards aimed at providing higher levels of sterility assurance.
Lead continuous improvement projects. To develop your personal lean/manufacturing excellence knowledge.
Working closely within your business area and other aligned support services, you'll participate with continuous improvement activities or projects so that they meet the agreed objectives.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and spark 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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours
Where can I find out more?
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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.