Automation Engineer

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Job description

Key Responsibilities:

  1. Automation System Design & Implementation:
  • Design, implement, and commission automated control systems for pharmaceutical manufacturing equipment, including PLC systems, SCADA systems, DCS, and HMI interfaces.
  • Ensure systems meet GxP (Good Automated Manufacturing Practice), regulatory, and industry standards.
  • Collaborate with the engineering and project management teams to design control strategies for various processes and equipment, ensuring safety and efficiency.
  • Manage the installation and commissioning of new automation equipment, including software, hardware, and integration with existing systems.
  1. System Maintenance & Troubleshooting:
  • Provide support for the troubleshooting and maintenance of automation systems to ensure the continuous operation of critical manufacturing equipment and processes.
  • Conduct preventative maintenance and resolve issues related to automation controls, instrumentation, and related software.
  • Perform root cause analysis (RCA) for automation system failures and implement corrective and preventive actions (CAPA) to prevent recurrence.
  1. Validation & Compliance:
  • Ensure that all automation systems and processes comply with relevant regulatory requirements (e.g., FDA, EMA, ISO, GxP).
  • Support automation system validation efforts, including IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) and documentation.
  • Assist in audits, inspections, and other compliance activities related to automation systems, ensuring all systems are validated and fully compliant.
  • Write and execute system documentation including SOPs, change control documents, and validation protocols.
  1. Continuous Improvement & Optimization:
  • Identify areas for process and automation improvement to enhance system performance, reduce downtime, and increase manufacturing efficiency.
  • Work with cross-functional teams to analyze process data and optimize automated systems to increase yield and reduce operational costs.
  • Implement Industry 4.0 technologies such as data analytics, predictive maintenance, and IIOT (Industrial Internet of Things) to optimize the automation environment.
  1. Project Management & Collaboration:
  • Lead and support automation-related projects, including system upgrades, new installations, and process optimizations.
  • Work closely with manufacturing, engineering, and IT teams to ensure the seamless integration of automation systems with manufacturing processes.
  • Manage project schedules, resources, and budgets while ensuring projects are completed on time and within scope.

Qualifications:

Education:

  • Bachelor’s degree in Automation Engineering, Electrical Engineering, Control Systems Engineering, or a related field.
  • Master’s degree in a relevant discipline is a plus.

Experience:

  • 3+ years of experience in automation engineering within the pharmaceutical, biotech, or life sciences industries.
  • Hands-on experience with PLC systems, SCADA, DCS, HMI, and MES (Manufacturing Execution Systems).
  • Solid experience with automation system integration, including control panel wiring, programming, and troubleshooting.
  • Experience in pharma or GxP-regulated environments is essential.

Skills:

  • Proficiency with PLC programming (Allen-Bradley, Siemens, etc.), and associated software like RSLogix, TIA Portal, or similar tools.
  • Strong working knowledge of industrial automation systems and related hardware and software.
  • Expertise in control systems (e.g., Honeywell, Emerson, Schneider Electric).
  • Experience with data analytics, predictive maintenance, and IIOT is a plus.
  • Strong knowledge of automated batch control and continuous manufacturing systems.
  • Excellent problem-solving skills and the ability to troubleshoot complex automation systems.
  • Familiarity with validation processes (IQ/OQ/PQ) and regulatory compliance (FDA, EMA, ISO).

Certifications (Preferred):

  • Certified Automation Professional (CAP) or similar automation certifications.
  • Six Sigma or Lean Manufacturing certifications.
  • Project Management Professional (PMP) or similar project management certifications.

Personal Attributes:

  • Strong interpersonal and communication skills, with the ability to collaborate effectively across functions.
  • Ability to manage multiple projects simultaneously while meeting deadlines.
  • A proactive and solution-oriented approach to problem-solving and troubleshooting.
  • Strong attention to detail and high standards for quality and safety.

Consultant

Paul O'Brien

Paul O'Brien

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