Automation/Process Control Engineer

Location: Macclesfield UK

Competitive salary and benefits

At AstraZeneca were redefining what a bio-pharmaceutical company can achieve. Our innovative approach opens up new ways to work pioneering groundbreaking methods and bringing unexpected teams together. Are you ready to turn complex automation challenges into reliable production that keeps lifesaving medicines flowing to patients If you are a self-motivated and expert engineer with a background in automation & control looking for your next challenge this fantastic opportunity to develop within Operations at AstraZeneca could be for you.

As an Automation Engineer you will strengthen the control systems that power our manufacturing network using digitalisation and Lean thinking to increase speed resilience and quality on the expansive Macclesfield campus where were driving ambitious redevelopment grounded in Chemistry Packing and Complex Parenterals. This is a fixed term role to support an exciting ongoing project and longer term the role will provide valuable experience which could lead to a future technical or project role.

Responsibilities:

• Project management of small projects including qualification technical and business improvements and budgetary control
• Delivering authoritative support to automation system faults and to quality incidents related to automated system functionality leading to Deviation and CAPA ownership
• Whilst maintaining Data Integrity generation of data from control systems to support digital transformation and data analytics
• Information Technology to Operational Technology interaction & support including patching and vulnerabilities planning and handling IT service weekends
• Use of Lean techniques such as problem solving and Tier reporting feeding into Total Productive Maintenance
• Delivery of automation system coaching to technical and non-technical staff including Engineering Technicians and Operating Teams. Mentoring of peers in your areas of expertise and being a mentee to learn from others.

Essential Skills/Experience:

• Experience of delivering and validating automation and control system projects in a GxP context
• Strong proven understanding of GAMP 5 21 CFR Part 11EU GMP Annex 11 Data Integrity (ALCOA)
• Ability to author and review high-quality validation documentation independently.
• Strong partner management and interpersonal skills.
• Diligent structured and proficient in working within a highly regulated environment.
• Minimum HND/HNC in a related subject area and meaningful work experience in a similar role or regulated industry

Desirable Skills/Experience:

• Degree or equivalent experience within a relevant field and membership of relevant institution with professional qualifications
• Familiarity with PLC/SCADA platforms (e.g. Siemens COPA Zenon).
• Exposure to MES or ERP interfaces related to packaging operations.
• Knowledge of Agile or risk-based validation approaches.
• Familiarity with lean manufacturing or continuous improvement initiatives
• Experience with serialisation and aggregation systems (e.g. Systech)
• ISA/IEC 62443 Industrial Cybersecurity Qualification
• Understanding of GAMP5 and the impact assessment of Category 1 3 4 5 changes
• Understand IT solutions to vulnerabilities e.g. patching and implement these on OT systems with no production or GMP impact.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work five days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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. Theres 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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