Technology Compliance Specialist

Job Description

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then.  The site plays a pivotal role in the manufacture of our Company’s biologics-based medicines, including immuno-oncology, and it has expanded our Company’s current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021. ​

Required

• Degree qualification in Science, Engineering, Information Technology, or a related technical discipline.
• Minimum 3 years' experience in Computer Systems Validation (CSV) within a GxP-regulated environment, preferably pharmaceuticals, biotechnology, or medical devices.
• Strong knowledge of CSV, Data Integrity, SDLC, and regulatory compliance requirements.
• Demonstrated ability to collaborate effectively across technical, quality, and business functions.
• Strong verbal and written communication skills with the ability to influence stakeholders at all levels.
• Experience supporting computerized systems compliance activities within manufacturing, quality, laboratory, or supply chain environments.
• Knowledge of one or more of the following areas: Automation, Instrumentation & Control Systems, IT Compliance, or Project Management.

Preferred

• Professional certification in Project Management (PMP) or IT/Compliance-related disciplines.
• Experience supporting or leading regulatory inspections and audits.
• Knowledge of SOX IT compliance requirements.
• Advanced degree (Master's) in a technical or scientific discipline.

We keep patients at the heart of everything we do and are committed to addressing some of the world's most challenging healthcare needs through scientific innovation and operational excellence.

As an equal opportunity employer, we value diversity and are committed to fostering an inclusive environment where talented and committed people can thrive and contribute their best work.

Should you require support during the recruitment process, please contact the Talent Acquisition Advisor assigned to this role.

We are committed to flexible working wherever possible and have introduced a hybrid working model for eligible office-based employees. We encourage candidates to discuss any flexibility requirements during the recruitment process.

Current Employees apply HERE

Current Contingent Workers apply HERE