Senior Biopharmaceutical Compliance Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeQuality Full time €60,000 - €80,000
Job Description

We are seeking a highly skilled Quality Engineer to join our engineering team at a biopharmaceutical facility in Ireland.

The successful candidate will support engineering projects and day-to-day operations with a strong focus on compliance, validation, and quality risk management.

Key Responsibilities:
  • Evaluate and ensure that all engineering activities are carried out in compliance with site quality standards.
  • Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls.
  • Support the commissioning and qualification (C&Q) lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports.
  • Lead or support investigations related to engineering deviations, non-conformances, and CAPAs ensuring timely closure and root cause identification.
  • Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, ensuring quality is embedded throughout.
  • Act as quality representative within engineering-led initiatives.
  • Support preparation for regulatory inspections and internal audits relating to engineering systems and GMP compliance.
  • Maintain and improve engineering quality processes.
Requirements
  • Degree in Engineering, Life Sciences, or a related technical discipline.
  • 5+ years' experience in a pharmaceutical, biopharma, or medical device environment.
  • Strong knowledge of validation principles and engineering best practices.
  • Hands-on experience with C&Q documentation, risk-based validation, and change management processes.

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