Position Summary
Responsibilities:
- 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.
Qualifications:
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.