AbbVie is a global biopharmaceutical company that strives to discover and deliver innovative medicines and solutions to improve patients’ lives across 24 therapeutic areas. We operate our Active Pharmaceutical Ingredients manufacturing site in Sligo, where the Technical Operations Team plays a pivotal role in ensuring product quality and regulatory compliance.
Senior Technical Analytical Specialist
We are looking for a Senior Technical Analytical Specialist to join our Technical Operations Team at our Active Pharmaceutical Ingredients manufacturing site in Sligo . The successful candidate will be the primary technical authority for analytical laboratory operations across routine and advanced testing, with accountability for compliance, verification, laboratory infrastructure, and support for a new laboratory.
Responsibilities & Duties
Provide analytical testing and technical support for routine, non‑routine and advanced applications, ensuring testing meets product, safety and quality requirements.
Lead compliance verification for analytical results, methods, equipment, records and data to ensure alignment with internal standards and external regulatory requirements (cGMP, GLP, ICH, FDA/HPRA, EHS).
Author, update and maintain SOPs, protocols and technical records to support audit readiness and regulatory compliance.
Oversee laboratory infrastructure, including asset management, equipment purchasing, qualification, maintenance and workflow optimisation, particularly for new laboratory spaces.
Perform advanced troubleshooting, technical investigations and support method validation, transfer and integration activities.
Collaborate with R&D, MS&T, Quality, Process, EHS and Lab Management to support knowledge transfer and operational alignment.
Mentor and coach analysts and project teams on compliance, verification, laboratory operations, equipment use and best practices (without formal people‑management responsibilities).
Support internal and external audits, regulatory inspections, CAPA development and quality system initiatives.
Drive continuous improvement in compliance, documentation, workflow efficiency, process modernisation and laboratory systems.
Ensure equipment is qualified, maintained and used in line with compliance and safety standards, with complete audit‑ready documentation.
Conduct calculations, report findings, and escalated analytical or verification issues to support high‑impact investigations and improvement projects.
Identify and help resolve safety hazards and non‑compliance issues in coordination with EHS and Lab Management.
Maintain accurate, complete and current records for all laboratory activities.
Complete handover of validated analytical methods to QC, ensuring a smooth transfer of knowledge, protocols and compliance requirements.
Qualifications
Degree or diploma in a science discipline.
5–7 years of experience in a similar role.
Extensive hands‑on experience with analytical techniques such as HPLC, GC, KF, dissolution, MS, XRD and others.
Strong expertise in method development, transfer, validation and troubleshooting.
Thorough knowledge of cGMP, GLP, ICH/CDER, FDA/HPRA and EHS requirements, with experience in compliance verification.
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only – to learn more, visit equal‑employment‑opportunity‑employer .
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: reasonable‑accommodations
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