Automation Engineer Senior
SimoTech requires an Automation Engineer (Senior) for a Biotech project in Dublin. Candidates must have at least 7+ years’ experience in operations/manufacturing environment in the pharmaceutical / life sciences industry.
- As a member of the Operations IS Automation team, the role will support complex and challenging system automation initiatives.
- Take ownership and administration of inspection equipment control systems in a GMP regulated manufacturing setting.
- Support manufacturing within the Vial/Syringe Inspection 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 and 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 regulations.
- Bachelors in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
- Minimum of 7+ 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 and validation of automated equipment.
- Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11.
- Solid leadership, technical writing, and communication/presentation skills.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- 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.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.