Automation Engineer III
Summary
This position is responsible for providing system administration; day to day support and maintenance of the site manufacturing automation systems. This work will include working independently with Manufacturing Operations, Quality, Outside contractors, site IT and Manufacturing Science groups. Support the automation and light process engineering for new product introductions, identifying and implementing continuous improvement changes in addition to providing system administrative services. The position may include night and weekend work as well as on-call coverage.
- Provide automation improvements based on Good Manufacturing Practices (cGMPs), particularly as they relate to the operation, validation and maintenance of manufacturing related computer systems including 21 CFR Part 11 Electronic Records, Electronic Signatures
- Manage the scope, schedule and budget for small to medium sized Automation engineering projects in addition to the technical aspects of the project when required
- Troubleshoot and maintain control system infrastructure including GE, Allen Bradley, and Honeywell
- Lead the design, commissioning, and implementation of control and automation engineering projects in cGMP manufacturing areas and supporting labs
- Implement proposed automation changes through local quality systems including Change Control and CAPA systems to meet the cGMP requirements of these proposed changes
- Responsible for project scope definition and construction management on automation project work conducted by internal personnel or contracted services
- Provide recommendations and assist with implementation of methods, procedures and techniques for improving automation of existing and new systems as well as assisting with system failure root cause investigations
- Provides manufacturing support, troubleshooting, and atypical resolution to ensure a consistent and reliable supply of products
- Develops and executes short-term and long-term plans to implement corrective actions for Automation based atypical events
- Must be available to work occasional nights, weekends, holidays and to provide 24/7 on-call support on a rotating basis
- Use of equipment design documents, manuals and drawings to troubleshoot problems
- The responsibilities of this position include hazardous and non-hazardous waste handling
Qualifications
- BS in Engineering (Chemical/Mechanical/Electrical), or equivalent work experience
- A minimum of 5+ years of experience in the pharmaceutical industry in Automation engineering
- Proven knowledge of cGMP manufacturing processes and related codes and regulations
- Thorough knowledge of SCADA and PLC based control systems including GE and Allen Bradley platforms
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