Automation Engineer – NPI

Overview

Support and manage control systems for NPI projects in pharma manufacturing.

Key Responsibilities

• project management
• control integration
• system validation
• troubleshooting
• continuous improvement
• automation initiatives

Tasks

To provide technical support and program management to all manufacturing operations and NPI’s. To provide technical leadership and control of all control system activities in the manufacturing facilities. -Project management and technical development of future integrations of the control systems, with planned MES and ERP systems. -Leadership of control system qualification activities during project start-up. -Develops and maintains close relationships stakeholders. -Wear PPE as required. -May provide leadership in sub projects related to commercial or NPI activities. -Supports successful introduction of NPI’s onsite. -Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines. -Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system. -Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times. -Define proposals for long term plans for control system maintenance and improvements for management. -Develops Automation system procedures to provide best value for the site -Provide technical leadership to functional areas and collaborates with key stakeholders. -Maintains systems in line with the latest guidelines on system and software integrity and validation. -Provide technical support to all control system related issues. Tasks include, daily trouble shooting, optimisation, and documentation control. -Completes all changes and updates with product and employee safety in mind. -Attend all required EHS training and medical surveillance programs. -Project management of control system elements of continuous improvement projects. Work closely with process engineers/ technical support chemists and other departments to deliver these continuous improvement projects. -Life cycle management of the onsite control systems, to GAMP-5 requirements. -Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system. -Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities. -Continually be conscious of your own safety and that of others, always complying with safety notices and barriers. -Adheres to and supports all EHS & E standards, procedures and policies. -May lead the delivery of new Automation initiatives.

Requirements

• b.eng
• plc
• scada
• ethernet
• osi-pi
• problem solving

What You Bring

Technical/Business Knowledge -Job Skills Cognitive Skills -Understands and supports the principles of Perfect Performance. -Sc or B. Eng Degree or Post Graduate Diploma in a relevant technical discipline. (Masters desirable) -Demonstrates an ethos of Right First Time at all times. -Requires innovative thinking, where new and untested solutions are proposed, demonstrated, and implemented on a regular basis. -Knowledge and experience of Ethernet based networks, and network architecture models. -3 years plus experience of plant start-ups and/or new product introductions to GMP facilities. Must be able to lead these activities in a start-up environment. -Knowledge and experience of the life cycle management of control systems, including backup, recovery, user access controls, configuration management and change management. -Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders. -Requires proven problem-solving skills under pressure. The position requires detailed evaluation of a number of viable solutions to each problem. -Shows a high level of tenacity to ensure closure of issues. -Strong interpersonal skills are required. -Knowledge and experience of Windows operating system administration. -3+ years experience in process automation, with relevant experience of Vendor Packaged Equipment in a GMP environment in the pharmaceutical industry. -Strong knowledge and experience of configuring and troubleshooting complex equipment control systems including PLC systems, and SCADA/HMI applications. -3 years experience of the 21 CFR Part 11 and EU Annex 11 requirements for automated systems in the pharmaceutical industry. -Knowledge and experience of interfacing systems with plant historians such as Ignition & OSI-PI using OPC interfaces. -Strong communication skills both verbal and written are required for the execution of this role. -Knowledge and experience control system networks, e.g. Profinet, Profibus, Modbus or CANBus.

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About Orion Group

-Founded in 2019 by a trio of entrepreneurs with a mission to consolidate boutique family-owned service brands. -Partnerships include Jackson Mechanical and specialized platforms in chiller, refrigeration, controls, and heavy mechanical. -Typical projects include multi-site retail HVAC roll-outs, preventive maintenance contracts, and large-scale landscape and snow-management programs. -Commercial landscaping services under its SunWorks banner manage grounds for corporate campuses and distribution hubs nationwide. -Its facilities maintenance network offers interior handyman, roofing, fencing, plumbing, locksmith, and exterior lot care with tech-driven coordination.

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