The Automation Engineer will support complex and challenging system automation initiatives. Individual will be will be responsible for providing support for existing Automation systems across the site.
The role requires a broad technical understanding of IS and Automation systems with a strong understanding of the applicable regulatory requirements, a desire for continuous improvement and right-first-time results.
The individual shall be structured in their approach to tasks and problem solving, organised, have a proven track record in delivering results and be able to work with minimal supervision.
Additionally, the role may involve carrying out work functions that are not described in this specification but are associated with their role. This position will report to the IS Senior Manager responsible for site automation.
- Ownership and administration of equipment control systems in a GMP regulated manufacturing setting
- Support Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Component Preparation and Packaging areas
- Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures
- Lead technical root cause analysis, incident investigations and troubleshooting issues related to electrical, instrumentation and equipment control systems
- Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
- Solving complex problems, project management, lifecycle management and operational excellence
- Develop and manage change control requests per established SOPs and processes
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulation
- Bachelors in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 4+ years' experience in operations/manufacturing environment
- Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
- Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment specifically in the areas of Formulation, Vial/Syringe Filling, Lyophilisation and Packaging
- Experience with Rockwell Automation PLC/SCADA/Batch, Siemens PLC/HMI, iFix, Wonderware, Elau/Kinetix Motion Control, ControlNet, DeviceNet, Profibus and OSIsoft PI Data Historian
- Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11
- Strong network architecture or engineering proficiencies 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 in developing automation strategies for new product introduction and new technology deployment
- Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
- Ability to influence the development of business area strategy and IT strategy where appropriate
- Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements
- Development and presentation of project plans to senior management
- Day to day vendor management and contract negotiations with focus on Automation Systems Integrators and OEM suppliers
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
- Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock on +44 (0) 203 0789 554 or upload your CV on our website www.proclinical.jobs . Full job description available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.