12272673 – Validation Engineer – Athlone Contractor

This is an 11-month contract position.

Purpose:

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 biopharma industry.

Responsibilities:

• Validation documentation – drafting, reviewing, and approving Validation documentation.
• Document coordinator support for Project and Sustaining operations at the Company.
• 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 the Document control archive, including reconciliation of the Document tracker.
• Developing a library of softcopy versions of all Validation test documentation.
• Supporting closeout of TrackWise actions for the 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.

Minimum Qualifications and 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 a 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 & on own.