Job Description

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\xe2\x80\x99s most serious disease. But we\xe2\x80\x99re more than one of the world\xe2\x80\x99s leading pharmaceutical companies.

As a high performing team, we are united and motivated by our shared purpose \xe2\x80\x93 to push the boundaries of science to deliver life-changing medicines. We come to work each day to make a difference \xe2\x80\x93 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\xe2\x80\x99s challenging and sometimes demanding, and that\xe2\x80\x99s 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

We are looking for someone who has experience with Moist Heat, Dry Heat and Radiation Sterilisation processes. They will be maintaining the validated status of sterilisation processes, managing local changes, continuous improvement and problem solving.

Key Requirements:

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 to have 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.

A scientific/technical degree background is desirable but experience in aseptic production environment and relevant experience of steriliser operation and validation would suffice.

Experience of working in a GMP environment.

Experience with the operation of sterilisers and sterilisation processes. This will include the application of current international standards and regulatory requirements for sterile product manufacture.

Understanding of managing new processes in the sterilisation process.

What you will be doing:

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 - Lead and ensure completion of experimental/validation work.

Working within a team to achieve operational delivery, within a complex and multidisciplinary production environment.

Lead problem solving and correction of problems associated with sterilisation issues.

Contribute to improving the compliance of the manufacturing operation with continuous improvement activities or projects.

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.

Review the performance of the sterilisation process regularly; to identify and resolve detailed weaknesses & respond to signals.

Understand the technical & quality specifications that define the process sequences within sterilisation processes.

Be responsible for the establishment of the acceptance criteria/specification of the sterilisation process and ensure that these specifications are consistent.

Support colleagues and wider technical network across site

Be fully engaged, informed and actively involved in the business area and understand my contribution to its overall goals and personal development.

Note: The Asset Sterile Engineering Specialist aligns to the Astrazeneca Sterile Support Officer Role

Why AstraZeneca?

At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and spark your entrepreneurial spirit. There\xe2\x80\x99s 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\xe2\x80\x99re on an exciting journey to pioneer the future of healthcare.

So, what\xe2\x80\x99s next?

Are you already imagining yourself joining our team? Good, because we can\xe2\x80\x99t 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\xe2\x80\x99s yours

Where can I find out more?

Our Social Media,

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Date Posted 19-Jul-2023

Closing Date 02-Aug-2023

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.

AstraZeneca