The Automation Engineer will manage the design, implementation and support for Plant-Wide Process Automation (PA) and Supervisory Control and Data Acquisition (SCADA) solutions within the West Chester, OH facility to support pharmaceutical development and manufacturing. Manage activities of 3rd Party engineering firms and PA/SCADA consultants assigned to plant IT projects and deliverables
- Review and approve requirements, specs, drawings, coding procedures and guidelines; and oversight of implementation, commissioning, and validation of control systems.
- Able to plan and schedule validation projects.
- Generate validation protocols (e.g. Traceability Matrix, Requirements, IQ and OQ)
- Coordinate with subject matter experts and development partners to align automation projects, resources and support activities with other site organizations and projects including Engineering, Operations, QA Validation, and QA Ops.
- Coordinate project activities with business owners, business partners, internal/external project team members and consultants.
- Consult as the subject matter expert on automation systems and processes within functional area.
- Ensure procedures, processes and SOPs are established and maintained for the design, development, validation and support of department solutions.
- Ensure solutions are compliant with FDA GxP validation including Part 11 and other regulations where appropriate.
- Work with the process engineering and development groups on developing and maintaining batch process recipes.
- Write, review and approve SOPs related to SCADA and Process Control systems.
- Train and coach manufacturing employees in the operation of new systems and processes.
- Initiate and maintain Process Control system infrastructure.
- Support projects and Systems Supported (including but not limited to): Automated aseptic filling lines; Automated bulk manufacturing lines; Automated utility control systems; Automated HVAC systems; SCADA/HMI systems and SCADA/Reporting systems.
- Apply knowledge and support for Good Automated Manufacturing Practices (GAMP5).
- Prepare protocols, reports, summary documents, equipment specifications and SOPS.
- Minimum BS in Engineering, Computer Science, or related area required.
- 3 years experience within a cGMP regulated industry, preferably in the pharmaceutical/biotech area.
- 3 years experience preferred in process automation and/or engineering. Strong emphasis on PLC/HMI based Automation Validation testing and execution.
- Well-organized; can manage multiple assignments at a time.
- Effective written and verbal communication and presentation skills.
- Ability to work independently and coordinate activities for various team members and stakeholders.
- Ability to manage multiple tasks and projects simultaneously. Self-starter/self-motivated.
Ability to lift up to 40 pounds unassisted. Ability to work day or night shift. Up to 20% travel. On-call support.
Frequently use a computer keyboard, PDA or other electronic or laboratory equipment or devices
Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.
Office, Laboratory and Manufacturing environment
Amylin Pharmaceuticals, Inc. - 11 months ago