LIMS Specialist

2 weeks ago

Cork, Cork, Ireland Test Triangle Full time
Overview

Role: LIMS Specialist / Validation Lead

Location: Co. Tipperary, Ireland

Department: Quality / Laboratory Systems

Industry: Pharmaceuticals

About the Role: We are seeking an experienced LIMS Specialist with pharmaceutical laboratory and validation expertise to support our state-of-the-art facility in Co. Tipperary, Ireland. The successful candidate will play a key role in introducing, validating, and maintaining LIMS to ensure laboratory efficiency, regulatory compliance, and data integrity in alignment with global quality standards.

Responsibilities
  • Lead the introduction, implementation, and lifecycle management of LIMS within QC and analytical laboratories.
  • Serve as Validation Lead, overseeing Computer System Validation (CSV) activities including URS, FS, RA, IQ, OQ, PQ, and validation reports.
  • Ensure compliance with EU GMP, FDA, EMA, Annex 11 standards for electronic systems.
  • Collaborate with Quality, QC, Manufacturing, IT, and Regulatory teams to optimize lab workflows supporting MDI/DPI product testing.
  • Support integration of analytical instruments and other quality systems with LIMS.
  • Provide user training, troubleshooting, and continuous improvement support for lab personnel.
  • Drive change control, deviation management, and periodic review processes related to LIMS and associated systems
  • Maintain audit readiness, ensuring documentation and processes align with corporate and regulatory requirements.
Qualifications & Experience
  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or IT/Computer Science.
  • 5+ years' experience in pharmaceutical/medical device industry with focus on QC laboratories, LIMS implementation, and validation.
  • Strong expertise in CSV methodology, validation protocols, and regulatory frameworks .
  • Proven track record in introducing and validating LIMS solutions (e.g., LabWare, Thermo Fisher SampleManager, STARLIMS, or equivalent).
  • Expertise in analytical techniques, including method development, troubleshooting, and non-routine analysis.
  • Comprehensive knowledge of cGMP, pharmacopoeial standards (USP, EP, JP), and global regulatory guidelines (FDA, EMA).
  • Skilled in equipment and analytical instrument qualification, calibration, and validation maintenance.
  • Strong proficiency in laboratory systems, statistical analysis tools, and software for data management.
  • Excellent documentation skills, including accurate preparation and maintenance of SOPs, validation protocols, and technical reports.
  • Proven project management abilities, ensuring adherence to timelines, budgets, and quality standards.
  • Deep understanding of data integrity principles, validation documentation, and regulatory compliance.
  • Extensive knowledge of biopharmaceutical systems, including manufacturing, cleanrooms, and utilities.
  • Effective problem-solver in validation challenges, providing practical and risk-based solutions.

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