The Automation Engineer will have overall responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable. This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of pack lines, serialization and visual inspection systems within a sterile injectable manufacturing facility.
- Responsible for Periodic review of the Automation Systems
- Responsible for assuring various user levels have appropriate, documented training and authorization for access to engineering managed computer systems
- Responsibility for managing regulatory aspects of the sites networked engineering data collection, monitoring and SCADA systems
- Responsible for implementation of compliance initiatives including monitoring of system security procedures and practices, review of audit trails and system logins for compliance
- Design and implementation support for minor functional and process changes, either smaller projects, remediation activities or capital projects
- Support future capital projects and assure site automation standards are followed
- Assist other departments in evaluating historical process/equipment data
- Provide automation guidance and training to other functional groups (ie. Operations, Validation, Maintenance, etc)
- Author and/or review design documents for projects and process changes
- Support FAT/commissioning/qualification activities as required
- Responsible for backup/archiving/restoring of Automation configuration and batch
- Develop and implement site automation standards for hardware and software
- Develop automation Standard Operating Procedures
- System Admin for all site SCADA systems, Data Historians, and Engineering Site–wide Software Applications
- System Administration for adding and disabling user access to Site Automation system
- Maintain Manufacturing level network, control level networks and Process I/O network.
- Bachelor’s degree in Engineering (Chemical, Computer, Mechanical or Electrical).
- Five years of working experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment.
- Understanding of SOP’s, Change Control and all related GMP Pharmaceutical systems.
- Ideal candidate must have process automation experience with integrated manufacturing systems and ancillary equipment.
- Hands on experience with Systech Vision System / TIPS, OPTEL Vision System / Serialization – LineMaster, PharmaProof, OSM Server, Rockwell Systems, iFix GE and Wonderware.