Process Capability Owner

3 weeks ago

Macclesfield, United Kingdom AstraZeneca Full time

**Process Capability Owner - 12 month FTC/Secondment opportunity**

**Location: Macclesfield, UK**

**Competitive salary and benefits**

**Opening date: 23/05/23**

**Closing date: 06/06/23**

At AstraZeneca, we put patients first and strive to meet their 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 nearly 100 global locations here at AstraZeneca, providing an excellent environment and 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.

The Process Capability Owner is a member of the Process Capability Team, which is part of the largest manufacturing department at UK Operations Macclesfield Campus. The Department is part of the larger UK Operations function, within Global Operations. The Technical Team has responsibilities for all aspects of process capability, robustness and continuous improvement associated with an aseptically manufactured product and associated materials manufactured at Macclesfield.

You'll support manufacturing activities by problem solving, providing technical responses as well as planning, leading and executing projects largely focused on continuous improvement and increased output across the Department, working to high standards of GMP.

**Responsibilities**:
With appropriate coaching and support from the Team and Technical Manager, you will demonstrate the skillset required for the role, including:

- Building your technical knowledge of the manufacturing process and respond independently to requests from the Plants for technical responses and to propose potential improvements to minimise recurrence.
- Process capability and Continued Process Verification (CPV) are at the core of the role. You’ll demonstrate an understanding about what is and is not a “capable” process and be involved in the routine CPV process.
- Examine and investigate returned customer complaint samples, writing clear reports to summarise your findings.
- With product demand continuing to increase, our focus is on how we can reduce waste and improve yield to improve our output and efficiency. This will involve you in improvement projects, either directly managing projects or being a key team member in more complex projects.
- You will be expected to complete the Lean Capability Framework training, giving valuable knowledge and experience of operating in a Lean manufacturing environment. This includes training in structured problem solving techniques, after which you will lead problem solving activities and implement solutions.
- Show an understanding of the regulatory boundaries within which the process must operate and therefore ensure that all of your work is completed compliantly and in accordance with GMP.
- Build your knowledge of experimental and validation activities (in both process and cleaning areas), authoring supporting documents as required, with appropriate support.
- Work within a team to achieve operational delivery, within a complex or multidisciplinary production environment.

**Essential Skills**:

- A scientific/technical degree background, or foundation level experience in an aseptic production environment and proven experience of manufacturing equipment and processes.
- Strong technical background in a complex manufacturing environment.
- Ability to understand and interpret Statistical Process Control and Capability.
- Problem solving and analytical skills to develop solutions/make judgements within general operating guidelines.
- Project Management skills and innovative in challenging ways of working and proposing alternative methods of working.

**Desirable Skills**:

- Sound working knowledge and understanding of pharmaceutical manufacturing processes.
- Six Sigma Green belt qualification
- Coordinated supply chain understanding.
- Understanding of LEAN principles.

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.

There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Interested? Come and join our journey

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