Senior Validation Engineer - Automation

About Amgen

Amgen is a pioneering biotechnology company established in 1980, dedicated to discovering, developing, and delivering innovative human therapeutics. The company has been at the forefront of transforming new scientific discoveries into safe and effective medicines, benefiting millions of patients worldwide by combating cancer and other critical diseases. Amgen's expansive pipeline reflects its ongoing commitment to advancing science and improving patient health outcomes.

Role Overview

The Senior Validation Engineer will be based at Amgen's Dun Laoghaire site in County Dublin, an aseptic drug product facility specializing in formulation, vial/syringe filling, lyophilization, inspection, and packaging. This role involves maintaining high standards of automation system operation and compliance, supporting continuous improvement and innovation within the facility as Amgen expands its global production capabilities.

Primary Responsibilities

• Ensure a safe workplace by strictly adhering to all relevant environmental, health, and safety regulations.
• Manage validation and maintenance processes for automation systems, including annual security and audit trail reviews, periodic system evaluations, and preventive maintenance.
• Provide expert Kneat system Super User support to aid the team.
• Execute hands-on tasks and assist colleagues with documentation to uphold consistent standards and compliance with approved templates.
• Take ownership of all Automation compliance documentation such as Standard Operating Procedures, Data Integrity Assessments, and operational guides.
• Engage in global compliance meetings to influence compliance execution direction and integrate learning back into the team.
• Lead deviation management by overseeing triage, investigations, root-cause analysis, impact assessments, and follow-up to ensure compliant and timely resolution of issues.
• Drive validation maintenance improvements by spearheading initiatives that enhance process efficiency and adopting innovative technologies including AI tools and advanced data analytics.
• Review team compliance task execution to identify opportunities for continuous improvement.

Preferred Qualifications and Experience

• Minimum of 5 years' experience in compliance or automation roles within manufacturing or operational environments.
• Bachelor’s degree in Engineering or Life Sciences with solid experience in operational or manufacturing settings.
• Comprehensive knowledge of regulatory frameworks and standards including GAMP software lifecycle, ANSI/ISA-S88 and S95 standards, 21 CFR Part 11, and Annex 11.
• Proficient understanding of automation and network technologies; prior experience with Kneat software is advantageous.
• Demonstrated ability to work independently, manage multiple priorities efficiently while staying organized in a manufacturing context.
• Effective team collaborator who fosters a team-oriented culture and supports collective decision-making.
• Strong communication skills encompassing technical writing, presentations, and interpersonal interactions.
• Proven competence in relationship-building and stakeholder management to coordinate efforts across various departments.
• Flexibility to travel as required for training or vendor engagements.