Job Description
Our Companys Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.
The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch.
The Schachen Biotech Process Automation team provides a strategic link between our early and late-stage pipeline and is responsible for developing and maintaining the Line of Sight for new technology and innovative processes. As part of a scale-out philosophy, we are seeking a Senior Automation Engineer who will support DeltaV / MES Recipe and Technology Transfers and alignment from Process Development to the local site and then to our late-stage BioNX Facility at Dunboyne in Ireland.
The Senior Automation Engineer will provide dedicated automation support, evaluation and implementation of process controls for novel equipment, innovative processes, and the implementation of next generation technologies to keep our Company at the forefront of innovation in development and clinical manufacturing of biologics. The incumbent will be responsible for troubleshooting in compliance with cGMPs of various manufacturing systems within our biotechnology facility, and actively contribute to continuous improvement projects for the development and clinical manufacturing of biologics as part of the Biotech Process Automation team in the Technology and Engineering Department.
Bring energy, knowledge, innovation to carry out the following:
Inspire Diversity and Inclusion building effective working relationships within a cross-functional team across different cultures and backgrounds.
Serve as a Subject Matter Expert for the implementation of control strategies for new equipment to enhance manufacturing processes in a Good Manufacturing Practice (GMP) environment.
Implement innovative technologies, software, control strategies, and instruments to streamline processes and reduce the effort involved in manufacturing and administrative processes.
Provide key automation support for various manufacturing systems such as DCS (DeltaV), MES(PAS-X), PLC, SCADA, and OEM systems.
Support and/or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentation.
Responsible for troubleshooting challenging equipment/automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP.
Transfer of Process Technologies from early-stage pipeline facilities and drive to GMP Operational Status, and support line of sight to commercial supply.
Lead automation related investigations into deviations and implement corrective actions.
Serves as the automation technical lead for site capital projects.
Working with external companies, organizing spare parts and service visits.
Supporting the qualification of new systems. Write, review, and/or execute test documents.
Collaborates within the Operations, Quality, Validation and Technical organizations to resolve complex problems.
Participate and actively support Digital Transformation initiatives involving system integrations, data connectivity, data analysis/modelling, validation methods and value-based optimization of manufacturing via process control system.
Limited off shift work may be required to meet project, operations, and qualification needs.
What skills you will need:
In order to excel in this role, you will more than likely have:
Bachelors degree in a Life Science discipline or equivalent practical experience of at least 5 years of experience in automation controls.
Thorough knowledge of computer validation/SDLC requirements and automation change control procedures. (e.g., GAMP 5)
Effective oral / written communication skills in English (C1).
Proven experience with DeltaV Batch, including the ISA S95 and S88.
At least 3 years of experience in an Automation or Engineering function for Biologics or Pharmaceutical industries.
Proven experience with development and implementation of industrial controls such as DCS (Delta V), MES (PAS-X), Histo