Sr. Validation Engineer - Automation

Biopharma Careers; Dún Laoghaire; On-site; EUR 77,000 - 104,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Automation

Compliance

GAMP

ISA-S88/S95

Data Integrity

Documentation

Validation

Kneat

Audit

Networking

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Science

Tools

Kneat

PLC/SCADA

Job description

Career Category

Engineering

Job Description

Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was among the first to turn new science into safe, effective medicines for patients. Its therapeutics have changed medical practice and helped millions worldwide fight cancer and other serious illnesses. With a broad pipeline of potential new medicines, Amgen remains committed to advancing science to improve lives.

Key Responsibilities

• Help to maintain a safe working environment by following all relevant environmental, health, and safety practices and regulations.
• Manage all processes required to keep automation systems in a validated state, including: Annual security and audit trail reviews
• Periodic system reviews
• Preventative maintenance
• Kneat Super User support
• This role combines direct task execution with support for team members completing documentation, ensuring consistent standards and adherence to approved templates.
• Own and maintain all Automation compliance documents such as Standard Operating Procedures, Data Integrity Assessments, and Guides.
• Participate in global meetings on compliance topics, influencing the direction of compliance execution and bringing learnings back to the team.
• Lead deviation management for the team, including triage, investigation, root-cause analysis, impact assessment, and follow-up actions to ensure issues are resolved in a compliant and timely manner.
• Champion validation maintenance within the group by leading initiatives that strengthen and streamline execution. Lead team initiatives to introduce new technologies that support validation maintenance, including the use of AI tools and the innovations in data analytics.
• Review execution of compliance tasks by the team to measure and drive continuous improvement.

Preferred Qualifications and Experience

• Experience: At least 5 years’ experience in a compliance or automation role within an operations or manufacturing environment.
• Education: Bachelor’s degree in Engineering, or a life science discipline, with at least 5 years’ experience in an operations or manufacturing environment.
• Compliance knowledge: Working knowledge of the GAMP software development lifecycle, ANSI/ISA-S88 and S95 standards, 21 CFR Part 11, and Annex 11.
• Technical knowledge: Working knowledge of automation and network technologies. Previous experience with Kneat is preferred.
• Work style: Independent, self-motivated, organised, and able to manage multiple priorities in a manufacturing environment.
• Collaboration: Strong team player who embraces a team-based culture and supports effective decision-making through collaboration.
• Communication: Excellent technical writing, communication, and presentation skills.
• Stakeholder management: Proven ability to build relationships, coordinate across departments, and collaborate with teams to achieve shared goals.
• Travel: Availability to travel as needed to support training and vendor visits.

Salary Range

76,859.55 EUR - 103,986.45 EUR