Senior Automation Engineer

2 weeks ago

Dundalk, Ireland Controlsoft Automation Systems Ltd Full time

Duties & ResponsibilitiesManage the specification, development, installation and validation of automation projects within budget and corporate guidelines.Lead and manage multiple concurrent automation system migration projects (e.g., PLC, SCADA, DCS, BMS, EMS, MES).Act as technical lead for defining migration strategies, timelines, resource plans, and risk assessments.Work with cross-functional teams to ensure minimal impact to manufacturing operations and compliance with GMP/21 CFR Part 11/Annex 11.Lead efforts in system architecture design, I/O migration, network reconfiguration, and system integration.Manage automation vendors and integrators, ensuring delivery meets technical and quality standards.Ensure validation and qualification activities are aligned with regulatory requirements (e.g., IQ, OQ, PQ documentation).Attend control system hardware and software FATs.Support change control processes, including documentation, implementation, and deviation handling.Mentor and provide technical guidance to junior engineers and automation support staff.Required Qualifications and Experience:Bachelor's or Master's degree in Electrical Engineering, Automation, Mechatronics, Computer Science, or related field.Minimum 7+ years of experience in automation engineering, with at least 3 years in a senior or lead role in a regulated pharmaceutical or biotech environment.Proven experience leading control system migrations, ideally from platforms such as:Siemens S7 / PCS 7Rockwell Automation / Allen-BradleyStrong knowledge of GAMP 5, CSV, and data integrity principles.Understanding of ISA-95, ISA-88, and good software development practices.Excellent project management, stakeholder engagement, and documentation skills.Familiarity with industrial communication protocols (Profibus, Modbus, OPC UA, Ethernet/IP).Experience with Batch systems, MES integration, and historian systems (e.g., PI, FactoryTalk Historian) is a plus.Preferred CertificationsPMP or equivalent project management certificationGAMP 5 training/certificationSix Sigma or Lean Manufacturing exposureVendor certifications (e.g., Rockwell, Siemens, Emerson)Work Environment:Cleanroom and GMP-regulated production areasInteraction with global engineering teams and site leadershipParticipation in audits and regulatory inspections as SMEReporting LineReports to:ClientAutomation Manager / Engineering LeadDirect Reports: May include Automation Engineers or Technicians, depending on project scope.

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