Packaging Validation Engineer

This is what you will do:

The Validation Engineer will prepare the necessary documentation and monitor progress for technical projects across the organization.   The incumbent will be a contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the bio pharma industry.

The Validation Engineer is responsible for management on all equipment validation testing documentation, development and execution of protocols, within a GMP environment.

The Validation Engineer will manage both project and sustaining Validation activities within the Packaging Department at ADMF. The individual will be required to utilize the Risk Based Verification (RBV) approach to execute equipment qualification activities (upgrades to existing Packaging Lines and new Medical Device Assembly Technology) in Alexion’s cGMP manufacturing plant in Dublin, Ireland. This individual will be required to work in a cross functional team and independently to accomplish validation objectives. The role will include engaging in early stage of projects, providing input into design, attending FATs and design reviews ensuring validation requirements are met in line with regulatory expectations.

You will be responsible for:

• Support sustaining and project Validation activities across Packaging and Medical device qualification.
• Provide validation support in introducing equipment and process improvements to existing equipment.
• Input into the core aspects of Operations, Qualification and Validation SOP's.
• Participate in Validation Risk Assessments to determine the level of testing required for new equipment.
• Lead in Validation Risk Assessments to determine the level of testing required for new equipment.
• Experience with serialisation requirements and processing is required for this role
• Act as Validation SME on packaging and medical device equipment and systems.
• Responsible for providing expert technical support in validation to meet the objectives of quality, output and cost in developing trouble shooting, standardising and improving new and existing equipment.
• Support regulatory inspections for both new and existing products manufactured within the Packaging area
• Assure that all validation test procedures are in line with current technology, Alexion, and regulatory requirements.
• Provide validation support in introducing equipment, process improvements and new products.
• Ownership and Closure of open issues (Deviations etc.)
• Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
• Lead troubleshooting and remediation project teams as required.
• Complete Periodic Reviews for Qualified Equipment
• Participate in problem solving teams across all areas in Alexion
• Be a champion for safe working practices and safety initiatives within their functional area.
• Proactively keeping up to date with current thinking and best practice.

You will need to have:

• 3-4 years of experience in a relevant role
• Excellent technical abilities with a solid base in engineering.
• Ability to keep work pace and meet deadlines. Good organisation and planning skills.
• 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 quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.

We would prefer for you to have:

• Technical Degree in Engineering/Life Sciences or greater preferred.

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.