Hybrid Tech Compliance Specialist - CSV & Data Integrity

MSD; Dublin; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

MSD in Dublin's Biotech facility seeks a Technology Compliance Specialist to ensure CSV, data management and SDLC compliance across the DMO and site. You will provide IT compliance and CSV expertise to safeguard the SDLC, support inspections and maintain data integrity.

Requirements include a degree in science/engineering/IT and a minimum of 3 years' CSV experience in a GxP environment, plus strong cross-functional collaboration and communication skills.

Qualifications

• Degree in Science, Engineering, IT or related field.
• Minimum 3 years' CSV experience in a GxP environment.
• Strong knowledge of CSV, Data Integrity, SDLC and compliance requirements.
• Ability to collaborate across technical, quality and business functions.
• Excellent verbal and written communication; stakeholder influence.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity and IT Security policies.
• Manage change controls, periodic reviews, access management, disaster recovery, audits and CAPAs.
• Support applicable regulations including EU Annex 11, 21 CFR Part 11 and SOX.
• Coordinate regulatory audits and inspections; liaise with auditors and manage documentation.
• Serve as SME for DMO validation processes and risk management.
• Maintain inspection readiness through reviews, mock audits and remediation.

Skills

CSV Compliance

Data Integrity

SDLC

Regulatory Compliance

Cross-functional Collaboration

Communication Skills

Audit Support

GxP Knowledge

Education

Bachelor's degree in Science/Engineering/IT

Master's degree (adv)

Tools

Audit Management Tools

Job description

MSD in Dublin's Biotech facility seeks a Technology Compliance Specialist to ensure CSV, data management and SDLC compliance across the DMO and site. You will provide IT compliance and CSV expertise to safeguard the SDLC, support inspections and maintain data integrity.

Requirements include a degree in science/engineering/IT and a minimum of 3 years' CSV experience in a GxP environment, plus strong cross-functional collaboration and communication skills.