Engineer - Automation/Instrumentation - III (Senior)
3 weeks ago
This role is to provide automation support to our vaccine manufacturing facility.
Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.
Actively support, participate and embrace a diverse and inclusive culture including significant interaction with manufacturing, quality and engineering groups. Supports a broad spectrum of automated systems within GMP Manufacturing Operations.
Key Functions
•Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
•Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities.
•Responsible and accountable for supporting all automation system components of the processes including on the shop floor support of manufacturing activities
•Responsible for designing, implementing, testing, and closing-out change controls for automation related corrective actions and continuous improvement initiatives.
•Participate in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
•May require to provide off-site weekend/evening automation phone or on-site support as needed.
Quals
Education- Bachelors preferred but Associates acceptable (with good experience).
Required-
3+ years in process automation or equivalent in pharmaceutical/ biotechnology industry.
•Familiarly with Computer system validation and regulatory GXP requirements.
•Knowledgeable of S88 Batch Standard
•Strong communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external parties.
•Technical and operational expertise in automation control systems such as Emerson DeltaV, AB PLC, Factory talk, SCADA, Windows operating systems, network infrastructure, SQL, etc.
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