• ey Responsibilities:Responsibilities include, but are not limited to:Perform initial feasibility assessments, concept development, and project cost estimates.
• Support and manage project-related change control activities in accordance with site procedures.
• Monitor project milestones, deliverables, and overall execution to ensure successful completion.
• Create, maintain, and oversee detailed project schedules and timelines.
• Coordinate communication and activities between internal stakeholders, external suppliers, contractors, and project teams.
• Develop User Requirements Specifications (URS) for automation projects in collaboration with system owners and business representatives.
• Work with the IT department to define and request the infrastructure required to support automation systems, including virtual environments, network hardware, and associated IT resources.
• Coordinate and manage the engagement of automation system integrators.
• Oversee automation project execution, including software development, Factory Acceptance Testing (FAT), site installation, commissioning, startup support, Site Acceptance Testing (SAT), and User Acceptance Testing (UAT).
• Prepare, review, execute, and approve validation and lifecycle documentation within the electronic document management system, including FDS, RTM, QAP, QASR, FAT, SAT, and IOQ documentation.
• Provide subject matter expertise on company automation standards, validation practices, hardware and software platforms, and associated business processes to ensure compliance and consistency across projects.

• Skills & Experience:Essential QualificationsBachelor's degree in Engineering, Computer Science, or a related technical discipline.
• Minimum of three years' experience delivering automation or control systems projects within an industrial or regulated environment.
• Strong knowledge of cGMP requirements, Software Development Life Cycle (SDLC) practices, and continuous improvement methodologies such as Lean, Six Sigma, or Manufacturing Performance Systems (MPS).
• Proven project management capabilities with the ability to coordinate multiple workstreams and deliver projects successfully.
• Excellent analytical, troubleshooting, facilitation, and decision-making skills.
• Demonstrated ability to assess business needs, define technical requirements, develop business cases, and recommend practical process or technology-based solutions.

• Preferred ExperienceHands-on experience with industrial automation platforms and technologies, including Building Management Systems (BMS), PLCs, HMIs, SCADA applications, process control systems, SQL databases, and plant historian platforms.
• Familiarity with client/server architectures used in manufacturing automation environments.
• Experience with building services and facility systems such as environmental monitoring, fire detection, and access control.
• Working knowledge of regulatory requirements including 21 CFR Part 11, data integrity principles, and computerized system validation.
• Previous experience delivering automation projects within a GMP-regulated manufacturing or pharmaceutical production environment.

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Requirements added by the job poster

• Authorized to work in Ireland