Sterilisation Capability Owner

Location: Macclesfield, UK

Competitive salary and benefits

Opening date: 02/01/2024

Closing date: Midnight on 16/01/2024

Would you like to apply your expertise, to the day to day running of the Sterile manufacturing process? 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 meaningful to us that you bring your full self to work every day.

We are looking for someone who has experience with Moist Heat, Dry Heat and Radiation Sterilisation processes. Thereby delivering process improvements, through reduced variability and improved process robustness. The role holder provides Routine/Project support to the business area. In maintaining the validated status of sterilisation processes, managing local changes, continuous improvement and problem solving.

Essential Requirements:

• Engineering or Science Degree or equivalent
• High levels of concern for standards and attention to detail with a self-motivating and proactive approach are also required.
• Experience of working in a GMP environment.
• Experience of 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.
• Working knowledge of data loggers used in the qualification process e.g Ellab/Fluke

What you will be doing:

• Lead and ensure completion of the schedule of steriliser qualifications
• Provide professional guidance (leadership and technical capability) for problem resolution
• Actively involved in projects either in a lead or support role.
• Use your problem solving skills, lean capability and manufacturing excellence knowledge.
• Take the lead role in developing and delivering education and awareness to colleagues of the key requirements and activities associated with effective steriliser qualifications and ongoing compliance.
• Contribute to internal and external regulatory inspections via technical input as an expert in sterilisation techniques.
• Build a strong network with suppliers and integrate them into plans to improve the sterilisation process.
• Propose, impact assess and implement change to sterilisation processes to ensure full regulatory compliance.
• Use networking skills to maintain knowledge of current standard methodology and developments in state of-the-art of sterilization processes.

There are so many fantastic 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!

Date Posted

Closing Date