Are you interested in taking the next step in your career with a pioneer in the biotechnology industry in Dublin, Ireland? Are you ready to challenge yourself in a fast-growing and highly-regulated sector? If you are an experienced automation engineer within GMP-regulated environments, you could be the perfect candidate for this opportunity! Don't hesitate, apply today!
Job Description
Our client in Dublin are seeking an experienced Automation Engineer to join their team to support critical automation systems for drug product manufacturing and site utilities in a GMP-regulated environment. The role focuses on day-to-day manufacturing support, system reliability, compliance activities, and continuous improvement across Syringe, Vial, and Utilities/BMS automation platforms.
Key Responsibilities
- Act as System Owner for automation systems
- Oversee automation system lifecycle management, including maintenance, validation, and obsolescence planning.
- Manage Change Controls, Deviations, and CAPAs associated with automation systems.
- Maintain robust system documentation, configuration control, backups, and software versioning.
- Provide on-the-floor and remote automation support during routine operations, shutdowns, investigations, and technology transfers.
- Lead or support incident investigations, root cause analysis, and corrective actions for automation-related issues.
- Ensure minimal downtime and high system availability for GMP manufacturing operations.
- Execute monthly and annual compliance activities related to automation systems.
- Ensure systems comply with GMP, Data Integrity, 21 CFR Part 11, Annex 11, and internal quality standards.
- Implement CAPAs, including software changes, updates to design documentation, and SOP revisions.
- Support and champion Industry 4.0 initiatives
- Support new product introductions, technology transfers, and system upgrades
Key Requirements
- Bachelor's degree in Automation, Electrical, Mechatronic, Control, Computer, Chemical, or Biotech Engineering, or related discipline.
- 5+ years' experience working in an operations or manufacturing environment, preferably pharmaceutical or life sciences.
- Experience in PLC & Control Platforms, SCADA / HMI / PCS, or Building Management Systems (BMS)
- Experience in Networks, Data & Integration
- Regulatory knowledge in GAMP software development lifecycle and 21 CFR Part 11 and EU Annex 11
- Proficiency in validation, testing, and documentation best practices in GMP environments
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid public holidays
Location: Dublin, Ireland | onsite
