Automation Engineer (5 days onsite) · Shannon
Overview:
Our esteemed client, a leader in the biopharmaceutical industry, is seeking a highly skilled Automation Engineer to join their team. This role involves the support, design, development, implementation, and maintenance of computerized process control and monitoring systems within a cGMP environment. The successful candidate will provide technical support to enhance system reliability and compliance, collaborate with cross-functional teams, and drive continuous improvement.
Key Responsibilities:
- System Design and Maintenance:
- Support the design, development, implementation, and maintenance of SCADA, PLC, and HMI systems.
- Provide technical support for existing systems to enhance reliability and compliance, recommending and implementing practical improvements.
- Technical Documentation and Validation:
- Prepare user requirement specifications, author functional/design/configuration specification documents.
- Support validation by preparing test scripts and executing validation protocols for computerized equipment.
- Subject Matter Expert (SME):
- Provide SME input for user requirement specifications, change controls, issue investigations, CAPAs, and Quality Events.
- Collaborate with IT, Manufacturing Validation, and other Quality functions to support new project initiatives and ongoing operations.
- System Ownership:
- Act as the System Owner for site PLC-based Control Systems, Building Management System (Trend), and Environmental Monitoring System (EnVigil).
- Monitor, maintain, troubleshoot, and investigate control systems hardware and software.
- Innovation and Compliance:
- Proactively seek and implement innovative solutions to improve system performance, reliability, and compliance.
- Ensure automation and control systems comply with regulatory requirements, implementing and validating systems according to SDLC methodology.
- Training and Support:
- Support training efforts for new equipment installations.
- Develop preventive maintenance strategies, SOPs, and various specification documents.
Major Activities:
- Collaborate with site and global stakeholders to define and develop automated solutions for equipment, instruments, and processes.
- Translate business, technical, and regulatory requirements into systems-level solutions during the development and deployment of automated processing technologies.
- Evaluate new technology and act as an SME for introducing process automation solutions into a GMP manufacturing setting.
Experience and Competency Requirements:
- Educational Background:
- Degree (level 8) qualification in Engineering or a related discipline.
- Professional Experience:
- Minimum 5 years' experience supporting computerized systems in a GMP-regulated environment.
- Good understanding of automation standards and architecture for batch process control, such as S88, and related automation systems (e.g., process control systems, manufacturing execution systems, process data historians like PI, and laboratory information management systems).
- Experience in pharma/biopharma manufacturing.
- Technical Expertise:
- Knowledge and experience with computerized biopharmaceutical equipment and systems, including SCADA, Delta-V, TruBio, MFCS4, Biobrain, Bioflo, BioCommand, and Unicorn software.
- Familiarity with specifying, installation, configuration, validation, and support of computerized systems like Single-use Bioreactors, Filter Integrity Testers, Cell Counters, HPLC, UFDF, Non-viable particle counters, benchtop balances, and various QC lab instruments.
- Experience with OT Networks, Server infrastructure, OPC technologies, and scripting.
- Proven programming and maintenance experience with PLCs and software applications across multiple industrial platforms.
- Communication and Teamwork:
- Ability to perform and communicate effectively within a multi-discipline team structure.
- Experience in designing, selecting, configuring, and testing automated solutions for manufacturing, including batch software, PLC-based control systems, HMI packages, SCADA systems, and standalone computerized equipment.
- Regulatory Knowledge:
- Familiarity with industry regulations and guidelines (ICH, cGMP, GAMP, PIC/s, HPRA, FDA) as they apply to ATMPs.
- Essential knowledge of 21 CFR Part 11 and/or EU Annex 11 requirements.
If you are a motivated Automation Engineer with a passion for innovation and compliance in a dynamic, GMP-regulated environment, we encourage you to apply.
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