Senior Validation Engineer — Automation & Compliance

Biopharma Careers; Dún Laoghaire; Vor Ort; EUR 77.000 - 104.000; Vollzeit

Zusammenfassung

Amgen Ireland in Dublin area is seeking an experienced Automation Compliance Specialist to join our manufacturing operations. You will maintain validated automation systems, manage deviation processes, and own critical compliance documentation.

The role requires hands-on technical knowledge of GAMP, 21 CFR Part 11 and Annex 11, support Kneat deployments, and collaboration with global teams to drive continuous improvement and data integrity across the site.

Qualifikationen

• At least 5 years in a compliance or automation role within operations or manufacturing.
• Bachelor’s degree in Engineering or life science with 5+ years in operations/manufacturing.
• Working knowledge of GAMP, ANSI/ISA-S88 and S95 standards, 21 CFR Part 11, Annex 11.
• Working knowledge of automation and network technologies; Kneat experience preferred.
• Independent, self-motivated, organized, and able to manage multiple priorities in a manufacturing environment.
• Strong collaboration, communication, and stakeholder management skills.
• Willingness to travel as needed for training and vendor visits.

Aufgaben

• Maintain a safe working environment by following EH&S practices and regulations.
• Manage processes to keep automation systems in a validated state, including annual security and audit trail reviews.
• Periodic system reviews and preventative maintenance.
• Kneat Super User support.
• Lead documentation and templates adherence; maintain SOPs, Data Integrity Assessments, and Guides.
• Participate in global compliance meetings and share learnings.
• Lead deviation management: triage, investigation, root-cause analysis, impact assessment, follow-up actions.
• Champion validation maintenance and introduce new technologies to support compliance.
• Review execution of compliance tasks to drive continuous improvement.

Kenntnisse

Automation

Compliance

GAMP

ISA-S88/S95

Data Integrity

Documentation

Validation

Kneat

Audit

Networking

Ausbildung

Bachelor's degree in Engineering

Bachelor's degree in Life Science

Tools

Kneat

PLC/SCADA

Jobbeschreibung

Amgen Ireland in Dublin area is seeking an experienced Automation Compliance Specialist to join our manufacturing operations. You will maintain validated automation systems, manage deviation processes, and own critical compliance documentation.

The role requires hands-on technical knowledge of GAMP, 21 CFR Part 11 and Annex 11, support Kneat deployments, and collaboration with global teams to drive continuous improvement and data integrity across the site.