Senior IT Applications Analyst - QC Lab Systems

We are seeking a Senior IT Applications Analyst-QC Lab Systems to join our IOPS IT team, supporting the configuration, implementation, and ongoing management of IT QC Lab applications and systems.

Location: Raheen, Limerick County

Work model/flexibility: Monday - Friday, 8:00am - 4:30pm

• Act as Technical SME and lead on QC Lab IT application initiatives, coordinating across business departments to gather, prioritize, and implement system enhancement requests.
• Own IT Applications change control processes including converting User Requirement Specifications to Detail Design Specifications, writing configuration test plans, and producing summary reports.
• Apply working knowledge of 21CFR Part11 across GxP computerized systems; identify and remediate compliance gaps and participate in regulatory audits and inspections.
• Act as the primary integration point between QC, IT, automation, and external vendors; evaluate vendor platforms and integration tools for orchestration capabilities and lead technical discussions with system integrators and software suppliers.
• Partner with Validation and Quality teams to ensure IT applications are implemented following a compliant development lifecycle approach.
• Configure tabular, trend, and label reports; lead system security access reviews and periodic audit trail assessments; provide on floor guidance and application level troubleshooting for end users.
• Prioritize day to day work assignments for analysts within the IT department to support application troubleshooting activities; train IT Applications team members and maintain up to date training records for self and direct reports.
• Support and maintain systems built on cloud and/or hybrid architectures in alignment with lab instrument connectivity and data flow requirements.
• Experience with cloud and/or hybrid architectures (AWS, Azure, or similar) preferred; project management experience; professional qualification preferred.

• BS/BA in Information Technology or a related field with a minimum of 5 years of relevant experience, or equivalent combination of education and experience.
• Strong knowledge of 21CFR Part11 and GxP computerized system compliance; experience participating in regulatory audits and inspections preferred.
• Understanding of lab instrument connectivity and data flows.
• Experience with cloud and/or hybrid architectures (AWS, Azure, or similar) preferred.
• Project management experience; professional qualification preferred.

Salary Range: €54,200.00 - €88,400.00.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.