Automation Engineer

Hobson Prior are looking for a Automation Engineer to join an accomplished pharmaceutical company on a permanent basis, located in London. Our Client aims to develop potentially curative treatments for serious diseases.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this position you will be responsible for converting business, technical, and regulatory requirements into system-level solutions.
• Managing technical work streams across functions throughout the entire project lifecycle.
• Ensure that equipment and systems are in compliance with the user and qualification requirements by preparing and entering equipment and system requirements, requirements for design qualification, and data integrity assessments.
• Ensure vendor Functional Design Specifications (FDS), Hardware Design Specifications (HDS), and Software Design Specifications (SDS) are reviewed.
• Ensure systems meet company standards, by providing technical oversight of FAT, SAT, IQ, and OQ testing.
• Providing automation and engineering support for vendor packaged equipment, building management systems, and environmental monitoring systems. Including monitoring, maintaining, troubleshooting, and investigating control system hardware, wiring, and instrumentation (may require out-of-hours support).
• Review and/or approve Preventive Maintenance Plans, SOPs, IQ/OQs, commissioning protocols, user requirements, acceptance testing plans, and functional specifications.
• Work with Quality and Computer System Validation personnel to ensure automation and adherence to GMP requirements.
• Maintain the site QMS system with Quality Events, change controls, CAPAs, and deviations.
• Implement innovative solutions to improve system performance, reliability, and compliance.
• Provide support for upcoming equipment installation and training efforts.
• Maintain Good Manufacturing Practice (GMP), Data Integrity, and Good Documentation Practice (GDP) and abide by the applicable procedures.
• Ensures own training is completed in a timely and GMP-compliant manner.
• Assure that my GMP documentation (including Issues, CAPAs, Change Controls, BMRs and audit/inspection actions) is closed on time and in RFT status.

Key Skills

• Effectively communicates and works with multidisciplinary teams.
• Analytical problem solving skills.
• Capable of communicating and leading others.

Requirements:

• A Bachelor's degree in mechanical, chemical, or electrical engineering from an accredited university is required.
• Minimum 5 years' experience developing or supporting automated systems.
• Experience with batch process control, including standards for batch process control.
• Process and environment experience in pharma/biopharmaceutical manufacturing.
• Experience with DCSs, PLCs and Software applications, ideally across a number of industrial platforms.
• An understanding of DCS, PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, and proprietary equipment controllers.
• Expertise in ControlNet, Ethernet IP, Modbus, BACnet, and Profibus protocols and architectures.
• Worked on requirements gathering, design, configuration, integration, and implementation of manufacturing process control systems, batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, and PC networking.
• Knowledge of FDA regulations relating to biologics and drugs.
• Understanding of FDA regulation 21 CFR Part 11 and EU Annex 11.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.