LIMS Specialist / Validation LeadPosition: LIMS Specialist / Validation Lead Location: Co. Tipperary, Ireland Department: Quality / Laboratory Systems Industry: PharmaceuticalsAbout 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.Key ResponsibilitiesLead 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 & ExperienceBachelor'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.