Validation Engineer

Dublin
Contract
Full-time

2 months ago

We are seeking a Validation Engineer to join our client's team within the biopharmaceutical sector. In this role, you will play a pivotal part in ensuring that equipment, processes, and systems are fully compliant with regulatory standards. You will work collaboratively with cross-functional teams to validate both new and existing manufacturing platforms, resolve quality issues, and uphold the highest standards of documentation and compliance.Key Responsibilities

Lead validation projects for new and modified manufacturing equipment, processes, and utilities (IQ, OQ, PQ protocols).
Write and review validation documentation: validation plans, protocols, reports, risk assessments, and change controls.
Collaborate with Quality Assurance, Engineering, and Manufacturing to resolve deviation investigations and CAPAs.
Perform validation and commissioning activities, including qualification testing and acceptance.
Support continuous improvement initiatives, focusing on process optimisation and compliance.
Ensure validation activities meet internal SOPs and external regulatory requirements.

Qualifications

Degree in a science, engineering or related discipline is essential
3+ years in validation engineering within a GMP-regulated biopharmaceutical or pharmaceutical environment.
Demonstrated experience with IQ, OQ, PQ lifecycle for equipment and processes.
Proficient in producing validation documentation and technical reports.
Excellent interpersonal, communication, and project management skills.

Morgan McKinley

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