Validation Engineer

1 day ago

Dublin, Dublin City, Ireland DPS Group Global Full time
Overview

We are seeking an experienced Validation Engineer to support the validation activities for a Syringe Filling Line within a sterile fill-finish facility. The successful candidate will ensure that all validation activities are executed in compliance with GMP standards and quality requirements.

Key Responsibilities
  • Generate, execute, review, and approve CQV test documentation including FAT, IVs, FTs, SATs, and PQs for the Syringe Filling Line.
  • Review, pre-approve, and post-approve validation protocols.
  • Contribute to site Validation Master Plans and Standard Operating Procedures (SOPs).
  • Collate and report relevant validation data and metrics.
  • Assist in exceptions, deviation resolution, and root cause analysis.
  • Review validation planning documents detailing overall project strategy.
  • Review and approve Qualification Summary Reports (QSRs).
  • Generate Validation Summary Reports (VSRs).
  • Support development of User Requirement Specifications (URSs) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).
Education & Experience
  • 6+ years' experience in Engineering or Validation within the pharmaceutical/biotechnology industry.
  • Technical qualification at third level (or equivalent) in Engineering or a related discipline.
  • Extensive knowledge and proven experience in executing validation activities for pharmaceutical/biotech projects.
  • Experience with sterile/biotech equipment in a pharmaceutical environment is highly desirable.
  • Strong knowledge of GMP and safety requirements.
  • Demonstrated strong communication and stakeholder management skills.
  • Experience with Paperless Qualification Systems preferred.
  • Solid understanding of risk-based approaches to commissioning, qualification, and validation in biotechnology.
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Engineering, Quality Assurance, and Project Management
Industries
  • Engineering Services and Pharmaceutical Manufacturing

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