Website Asset Recruitment
An excellent and exciting new permanent staff opportunity has arisen with our client a long-established and prominent biopharmaceutical products manufacturer at their advanced technology facility for an experienced Automation Engineer. Reporting to the Operations Technology Manager, the Automation Engineer will play a key role in the OT sustaining team, providing Subject Matter Expertise (SME), ownership and administration for process automation systems in a GMP regulated manufacturing setting.
§ Working closely with Manufacturing Operations, Maintenance, Quality, Validation and EHS personnel, the Automation Engineer will lead and support technical root cause analysis, incident investigations, troubleshooting and continuous improvement initiatives to ensure systems remain compliant and reliable.
§ Support new technology introductions and system upgrades, by leading automation design criteria, performing engineering assessments, implementing automation system configuration changes, engineering and qualification runs.
§ Responsibility for all admin activities for their systems (monitoring, backup-restore, periodic reviews, version control, change management and Life Cycle Management).
System Owner – Site Support
§ Ownership and admin of process automation systems in a GMP regulated manufacturing setting
§ Technical support to internal customer issues, resolve automation system related issues to mitigate the associated operational risks in the areas of continuous production activities, GMP Compliance, Business and EHS.
§ Lead and support technical root cause analysis, incident investigations and troubleshooting issues related to instrumentation and equipment control systems.
§ Lead and support system improvements, development of detailed specification, engineering documents, and SOPs.
§ Solve complex problems, deliver lifecycle management and operational excellence.
§ Develop and manage change control requests per established SOPs and processes.
§ Critically analysing designs of existing systems, developing and recommending continuous improvements in line with the latest technology and regulatory standards.
§ Implement a robust obsolescence strategy in place for site Computerised Systems /Equipment.
§ Support a safe working environment complying with all environmental health/safety practice, rules and regulations.
§ Be responsive to change and respond to the needs of the business as required.
System Owner – Project Support
§ Provide technical hardware, software and coding expertise to ensure new and upgraded systems are provided and maintained to meet business compliance and performance requirements.
§ Manage miscellaneous ‘small / medium projects’, which will include; responsibility for management & co-ordination of project definition, engineering design, purchasing, installation, commissioning & qualification of equipment.
§ Support new technology introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering and qualification runs.
§ Contribute to the development, implementation and maintenance of a Good Engineering Practice platform for effective delivery of projects.
Computerised System Life Cycle
§ Generate disaster recovery plans / procedure for site Computerised Systems (Configuration management, system backup).
§ To support CSV for site Computerised Systems (Commissioning, Qualification, Operation).
§ Support the review of Automation & Control maintenance plans.
§ Support the continuous improvement of the Computerised System Life Cycle.
§ Support reduction of Automation & Control maintenance plans via data driven equipment performance and FMEA assessment.
§ Create, maintain, and execute Automation & Control maintenance procedures for equipment / computerised systems, including use of appropriate personal protective equipment & safety procedures.
§ Develop training methods / plans to be used to train members of the Engineering team and across functions: Maintenance / Operations.
§ Provide computerised system configuration and user access management configuration management appropriate to each Computerised System.
§ Document and investigate Automation & Control adverse events in accordance with site Unplanned Event procedures.
§ Complete Quality system activities and records within respective due dates.
§ Act as subject matter expert for review and implementation of Automation & Control tasks.
§ Complete site training requirements.
§ Adhere to all site policies and procedures to maintain the culture of quality compliance with Good Manufacturing Practices and Good Documentation Practices.
§ Ensure Compliance with EHS systems and procedures e.g., ERT, Incident/Accident Investigation procedures etc.
§ Ensure contractors are working within safety guidelines, using correct procedures and equipment.
§ Ensure high standards of housekeeping are maintained in the area
§ Ensure closure of EHS actions raised in a timely manner.
§ Ensure attendance at EHS training modules as defined by the site training calendar.
§ Bring to the attention of supervisor / manager / Safety Rep., EHS any suggestions that can improve safety on site.
§ Ensure appropriate Personal protective clothing is worn at all times as detailed in SOPs.
§ Ensure participation in relevant EHS unplanned events and ensure accidents/incidents are reported in a timely manner as assigned by the area Manager.
§ 5+ years’ Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
§ Bachelor’s Degree in Automation & Controls , electrical engineering, Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
§ Experience with programming and troubleshooting PLC (e.g., Allen Bradley, Siemens), SCADA (e.g. IFix, InTouch, WinCC), PCS (e.g. Siemens PCS7), Batch Systems (e.g. iBatch and PCS7), and BMS (Cylon and Desigo)
§ Industrial Networking experience with ControlNet (CNET), DeviceNet, Profibus etc.
§ Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk AssetCentre, VersionDog, ThinManager, PRTG Network Monitoring and OSIsoft PI Data Historian.
§ Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, GAMP5, FDA 21 CFR Part 11 and EU Annex 11
§ Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls
§ Solid leadership, technical writing, and communication/presentation skills
§ Experience in change control, non-conformance, corrective and preventative actions, and validation practices
§ Experience and involvement with successful Pre-Approval Inspection or equivalent regulatory audit involving Programmable Electronic Systems is desirable.
§ Bachelor’s Degree in Automation & Controls, electrical engineering, Computer Science, Chemical Engineering, Biotech Engineering or related life science.
§ 2+ years’ experience required in configuring and maintaining programmable electronic systems used for process control, within a cGMP regulated environment (GAMP5, FDA 21 CFR11, EU ANNEX 11).
§ Experience with Siemens PLC/HMI, PCS7 and SCADA configuration and maintenance.
§ Aware of regulatory expectations together with the latest developments and automation issues within the global pharmaceutical industry (GAMP5, FDA 21 CFR11, EU ANNEX 11).
§ Working knowledge of network architecture technologies including TCP/IP, Active Directory
§ Proficient in problem solving, technical support, maintenance, specification and validation of Process Control system
§ Excellent understanding of Automation & Control principles.
§ Excellent Technical, analytical and organisational skills
§ Independent, self-motivated, organised and able to multi-task in project environments.
§ Clear and concise technical writing, and communication/presentation skills
§ Team player, prepared to work in and embrace a team-based culture relying on collaboration for decision-making.
§ Proficient in managing relationships with stakeholders, coordinating and collaborating with teams
Travel at various times may be required to support execution of projects