Automation Engineer
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Key Responsibilities:
- 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.
- 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.
- 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.
- 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.
- 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
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