Description:
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
The Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the manufacturing equipment across the organization. The incumbent will be a contributor in supporting the execution of the qualification studies relevant to the sterilization, depyrogenation processes and temperature-controlled units.
- Validation documentation – drafting, reviewing and approving Validation documentation.
- Execute Temperature mapping studies for controlled temperature units and / or manufacturing areas.
- Execute Sterilization and Depyrogenation qualification studies
- Participate in Validation Risk Assessments to determine the level of testing required for new equipment.
- Support sustaining and project Validation activities across Drug Substance and Drug Product Areas
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Maintaining hardcopy records in Document control archive, including reconciliation of Document tracker.
- Supporting closeout of TrackWise actions for Validation team
- Raising, supporting and resolving validation deviations as they occur.
- Coordinating a Validation dashboard update for site management / leadership
- Ensure Requalification and Periodic Review activities are completed in a timely manner
- Provide support in areas of commissioning and qualification of mechanical, process, electrical, automation equipment and systems and performance test protocols.
- Report / present out on project updates as required
- Encourage and sustain a high safety culture and performance within the Validation teams.
- Demonstrated ability to work effectively with various departments and resolve issues in structured manner.
- Strong technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own.
- Direct Experience with hands on qualification of Steam Sterilization Autoclaves and porous loads
- Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics
- Understanding of the Cycle Development and Performance requirements for the Porous Load sterilization
- Direct Experience with execution of Control Temperature Units and qualification requirements
- Direct Experience using thermal acquisition systems (wired thermocouple systems, data loggers)
- Understanding of the Aseptic Manufacturing processes
- Technical Degree in Engineering/Life Sciences