Sterilisation Capability Owner

England, Macclesfield, Cheshire
04 Jun 2021
22 Jun 2021
AstraZeneca UK
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Sterilisation Capability Owner

Location: Macclesfield, UK

Competitive salary and benefits

Opening date: 04/06/2021

Closing date: Midnight on 20/06/2021

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.

To work in partnership with the local business area/external supplier to define, measure, and control the sterilisation process. 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:

  • 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.
  • We a scientific/technical degree background is desirable but foundation level experience in aseptic production environment and relevant experience of steriliser operation would suffice.
  • Ideally you'll join us with experience of working in a GMP environment.
  • Naturally curious, you'll have the ability to learn and understand 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:

  • Propose, impact assess and implement change to product/sterilisation processes to ensure the business area is fully complaint and maintain process robustness.
  • Lead and ensure completion of experimental/validation work.
  • Ensure that the validation status of the steriliser & processes is maintained and accurately documented throughout BAU and any changes the process.
  • Review the performance of the sterilisation process regularly; to identify and resolve detailed weaknesses & respond to signals.
  • Display the sterilisation process via visual management techniques and obtain engagement in its importance and upkeep - including ongoing data collection to demonstrate control.
  • Ensure FMEA is kept live and put in place robust control plans which demonstrably mitigate impact of failure.
  • Map the process interactions by use of SIPOC/Process Sequence processes & identify the sources of variability for sterilisation process.
  • You will have identified the aspects of sterilisation process that require to be supervised.
  • Understand the technical & quality specifications that define the process sequences within sterilisation processes.
  • Work within the defined framework to drive the use of standard ways of working across the business area
  • Be responsible for the establishment of the acceptance criteria/specification of the sterilisation process and ensure that these specifications are consistent.
  • Utilise data analysis tools (i.e. RCM, Value mapping, Cpk, FMEA and MMI) to identify and prioritise improvement opportunities & risks for products/processes.
  • Introduce new processes into the business area where they can demonstrably add value, and support the area to exploit them to full potential
  • Be certain that the production process incorporates the learning from previous problem solving successes.
  • Attend relevant internal and external courses/symposia to ensure my knowledge is up to date.
  • Develop a comprehensive IDP to ensure required technical, personal and continuous improvement training is undertaken to support my core role.
  • Be a member of a relevant professional body/ institute to maintain currency of expertise for a sterilisation process/technology.
  • 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.

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!

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