APICOM Equipment Validation Engineer

at  AstraZeneca

ESSENTIAL SKILLS & EXPERIENCE:

• Bachelor’s Degree in Engineering/Life Sciences/Computer Science.
• Significant experience in a relevant role.
• Detailed knowledge of cGMPs, GLPs, GDPs, and Data Integrity requirements.
• Strong technical writing and communication skills.
• Strong awareness and understanding of the biopharma business, especially with regards to quality and regulatory requirements.
• Excellent technical abilities with a solid base in engineering.
• Ability to keep work pace and meet deadlines. Good organisation and planning skills.
• Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
• Ability to work independently and remotely with minimum direct supervision.
• Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
• Experience in sprayball coverage testing in process vessels

WHAT YOU’LL DO:

Initially, you’ll be part of a cross functional team providing project technical support on CQV activities and to ensure the design of the new APICOM facility is safe, efficient, and long-term operability is factored in.
Longer term, you will be responsible for development of the site validation strategy, validation plans, protocols and reports for all equipment and processes including Factory/Site Acceptance Tests, the development of Product validation risk strategies, and Installation/Operational/Production Qualifications. You will be required to use the latest class of digital tooling/systems to support validation to streamline processes.

You will perform activities in support of the validation program such as:

• Maintaining an annual periodic review of the validation systems/documents.
• Liaising with other departments and end users on the completion of risk assessment for any product line extensions, process improvements or automation projects.
• Verifying that completed validation studies have been adequately recorded, documented, and carried out, in accordance with the approved Validation Plan and Protocols.
• Ensure the preparation of validation protocols, process design specifications and associated documentation for equipment and systems.
• Participating in project teams and assisting in determining project schedules and the relevance of appropriate levels of validation.
• Control and compliance of calibration schedules and associated instruments.
• Develop and maintain existing and future document control practices.

This position requires both a strong technical background in Validation with the capability to collaborate effectively with both internal and external stakeholders.

ADDITIONAL RESPONSIBILITIES:

Key result areas, specific accountabilities, and/or tasks associated with the role:

• Equipment validation and CQV
• Problem-solving, technical support, learning
• Safety, Health and Environment
• GMP / Compliance and Ethical Conduct
• Delivery / Supply
• Cost
• Lean & Agile Culture / Standardised ways of working