Sr. Manufacturing Automation Engineer II
- Maintain the automation servers, systems and network devices for process equipment and systems
- Develop and implement strategies for data management and data flow through automation network.
- Locate and diagnose system failures and perform troubleshooting for automated process equipment and systems
- Develop solutions to automate manual tasks by implementing upgrades to PLCs, HMIs and SCADA systems
- Support the high levels of reliability for the Process Control System Information Management and Network Infrastructure
- Manage the standards, methods and procedures for the design, modification, and maintenance of manufacturing processes.
- Develop, modify and redline specifications for: mechanical and electrical contractors, equipment, software, hardware, P&ID, network topology, PFD, wiring diagrams, panel drawings, etc.
- Plans, executes and tracks a variety of engineering projects.
- Contributes to the development of department strategy.
- Coordinates cross-functional efforts to resolve manufacturing and maintenance issues in projects and day-to-day operational activities.
- May participate in audits to include internal, vendors or contract manufacturers.
- Implements systems for tracking project progress.
- Supports and contributes to site continuous improvement initiatives.
- Compiles and reports technical performance metrics.
- Maintains and develops existing engineering systems which support equipment run times.
- Develops lifecycle documents including URS, FDS, SDS, FAT, SAT, Commissioning, IQ, OQ, and PQ protocols.
Knowledge and Skills:
- Demonstrates extensive understanding and application of process engineering principles, concepts, practices, and standards.
- Demonstrates proficiency in current Good Manufacturing Practices (GMPs), 21 CFR Part 11/Annex 11, regulatory compliance, strategic planning, data management, and safety regulations.
- Demonstrates knowledge of pharmaceutical process manufacturing, OEE, MTBF, and root cause failure analysis.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications
Education and Experience:
- 7+ years of relevant experience, and a BS or BA or related fields.
- 5+ years of relevant experience, and a MA or MBA.
- Has experience with automated infrastructure that include: security strategies, network architecture, platform selection and full implementation of 21 CFR Part 11 and EU annex 11 requirements
- Has extensive experience in PLC-based programming (e.g. Rockwell software)
- Has previous experience with developing Audit, Event, and Batch reports and integrated into centralized reporting system.
- Has previous experience in biotech or pharmaceuticals industry.
- Has previous experience in engineering in highly-regulated manufacturing environments.