A global biologics company in Athlone is looking for a Validation Engineer who 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.
- Validation documentation – drafting, reviewing and approving Validation documentation.
- Document coordinator support for Project and Sustaining operations.
- Execute Temperature mapping studies for controlled temperature units and / or manufacturing areas.
- Participate in Validation Risk Assessments to determine the level of testing required for new equipment.
- Support sustaining and project Validation activities across Bulk Drug Substance, Packaging and Laboratory 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.
- Developing library of softcopy versions of all Validation test documentation
- 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.
Qualifications & Experience:
- Technical Degree in Engineering/Life Sciences
- 6 years+ relevant experience working in a Validation role in the Pharmaceutical / Biotechnology industry.
- Experience of upstream / downstream drug substance processes would be an advantage.
- Demonstrated ability to work effectively with various departments and resolve issues in structured manner.
- Strong technical capabilities, communication skills, teamwork abilities and initiative.
- Strong knowledge of regulatory requirements and current Health and Safety Regulations legislation.
- Proven ability to work well as part of a team & individually.c