Hybrid CSV & IT Compliance Specialist

Msd Ireland; Carlow; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

Merck & Co., Inc. in Ireland's Carlow site seeks a Technology Compliance Specialist to assure SDLC/CSV, data integrity, and IT security in a regulated manufacturing context.

You will provide expert guidance on validation strategy and risk management while maintaining inspection readiness and supporting audits. The role requires a Science/Engineering/IT degree and 3+ years in CSV within a GxP environment, with strong cross-functional collaboration and communication skills.

Qualifications

• Degree in science, engineering, IT, or related technical discipline.
• 3+ years in CSV within a GxP environment (pharma/biotech/medical devices).
• Strong knowledge of CSV, Data Integrity, SDLC and regulatory compliance.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity and IT Security policies.
• Execute change controls, periodic reviews, access management, incident investigations and CAPAs.
• Support audits and inspections, manage documentation and inspection tracking.
• Act as SME for DMO compliance and validation processes, guiding risk management.

Skills

Auditing Operations

CFR 21 Part 11

Computer System Validation (CSV)

Data Integrity

EU Annex 11

FDA Regulations

Gap Assessments

GAMP

QMS

SDLC

System Validation

Education

Bachelor's degree in Science, Engineering, IT, or related field

Job description

Merck & Co., Inc. in Ireland's Carlow site seeks a Technology Compliance Specialist to assure SDLC/CSV, data integrity, and IT security in a regulated manufacturing context.

You will provide expert guidance on validation strategy and risk management while maintaining inspection readiness and supporting audits. The role requires a Science/Engineering/IT degree and 3+ years in CSV within a GxP environment, with strong cross-functional collaboration and communication skills.