LIMS Specialist / Validation Lead
Position: 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.
Key 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.