Sterile Manufacturing/Vaporised Hydrogen Peroxide (VHP) SME Opportunities

AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Sterile Manufacturing/Vaporised Hydrogen Peroxide (VHP) SME Opportunities

Location: Macclesfield, UK

Competitive salary and benefits

Opening date: 26/01/2024

Closing date: 11/02/2024

Are you ready to make a significant impact on people’s lives with life-changing medicines? Do you have experience in Vaporised Hydrogen Peroxide (VHP) as part of Aseptic Manufacture? If so, this may be the opportunity you've been waiting for ! At AstraZeneca, we're dedicated to being a Great Place to Work where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Macclesfield is AstraZeneca's largest UK campus with a variety of work environments including laboratories, factories and offices. We are currently undergoing an ambitious campus redevelopment driven by AstraZeneca’s pipeline and grounded in our three core key value propositions – Chemistry, Packing and Complex Parenterals.

As part of this investment, we are installing two new Syringe Filling and Assembly (SF&A) lines for an established oncology drug. This is an exciting opportunity to apply your VHP expertise to provide both project and subsequent routine business leadership and support for the VHP decontamination processes on these lines.

Accountabilities:

We have exciting roles at a variety of levels that will lead and/or support the planning and execution of the VHP decontamination validation of two new syringe filling lines. You will ensure adherence to project schedule, deliver the new VHP qualification/requalification protocols and procedures, and provide transfer of knowledge of the VHP technology for when the new lines move into routine operation (planned for end of 2024). The roles will then transition from the project team to the operational Technical Team and provide either subject matter expert or technical support for maintaining the validated status of the VHP decontamination process.

You will provide support and leadership to the business area by defining, measuring and controlling the VHP decontamination process, qualification and validation activities associated with VHP, managing local changes, continuous improvement and problem solving.

You'll be required to effectively collaborate and work with different functions and partners of the project team and operations unit. You'll contribute to the establishment and maintenance of a robust new business process that meets all the regulatory and AstraZeneca standards.

You will be expected to maintain up to date knowledge and use the technical network to share industry standard methodologies and best practice.

The BAU technical team has responsibilities for all aspects of process robustness and continuous improvement associated with a unique aseptically prepared product manufactured at Macclesfield.

Responsibilities:

  • Provide both practical expertise/support and VHP knowledge and experience to the project and BAU technical teams.
  • Develop the appropriate experimental and qualification programmes, execute them and complete the associated reports to meet the standards required by regulatory authorities.
  • Apply advanced theory, make data driven decisions and use structured problem solving methodologies (e.g. A3 report/PDCA, Practical Problem Solving, Six Sigma) to define the new VHP decontamination business process and to address a range of issues during execution of the VHP qualification and its routine use.
  • Contribute to internal and external regulatory inspections via technical input as expert for VHP technology and sterilisation processes.
  • Proactively look for opportunities and propose solutions to establish a VHP business process which reflects the latest industry standards, improves product quality and maximises the efficiency of the manufacturing operation.
  • Develop strong relationships with Sterile Manufacturing Specialists, Production, Technical, Engineering and Quality functions to enable timely progression and resolution of issues positively and in the best interest of AstraZeneca.
  • Build a strong network with suppliers and integrate them into plans to develop new processes and improve current ones.
  • Support the development of new VHP training packages and deliver training to colleagues of the key requirements and activities associated with VHP decontamination.
  • In addition to VHP, sterilisation processes that fall under the remit of this role may occasionally include moist/dry heat sterilisation and gamma irradiation.

Essential Skills/Experience:

  • Good experience of VHP technology qualification, knowledge of the VHP theory, aseptic manufacture, sterilisation and basic microbiology
  • Good working knowledge of ISOs 13408, 14937, 17665
  • Practical experience with the use of Biological and Chemical Indicators
  • Ability to make complicated judgements ensuring compliance with cGMP and operating guidelines
  • Good numeracy skills with a systematic approach to problem solving and a structured mind-set
  • An inherent attitude to look for creative technical solutions to incorporate VHP/sterilisation technology into lean manufacturing
  • Hold high standards and good attention to details with a self-motivating, proactive and critical approach
  • Good planning and organisational skills
  • Strong verbal and written communication at all levels and effective influencing skills, particularly at first line manager level and group manager levels.

Desirable Skills/Experience:

  • Degree level or equivalent in a scientific/technical subject area
  • Proven experience as subject matter expert in VHP
  • Good working knowledge of ISOs EN 285, 11137
  • Experience with Enzymatic Indicators (EIs)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

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.

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