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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