Job Description
Are you interested in taking the next step 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!
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
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