- Performs specialized activities related to design, commissioning, performance improvement, and troubleshooting of computer control assisted processing equipment.
- Provides and develops design/approval of hardware, software, and controls for computer assisted equipment.
- Evaluate/implement process control, process monitoring, data acquisition and other support requirements for manufacturing.
- Implements software/hardware changes and upgrades, understands impact of actions to Manufacturing and Facilities and process.
- Implements modification/change control procedures and protocols.
- Programs PLC and HMI application for automated process equipment, capable of troubleshooting and demonstrates knowledge of instrumentation and controls.
- Development of Standard Operation Procedures (SOPs), Preventive Maintenance (PM's), and calibration forms.
- Provide support to the calibration group and assist with the existing calibration program when required.
- Provide support to Project Engineers regarding related departmental activities specifically to process control and automation.
- Provide project management for all assigned projects and assignments.
- Prepare detailed capital project requests, equipment procurement specifications and vendor's contracts as per overall guidelines.
- Coordinate with vendor for inspection and testing of new equipment, supervises the installation and commission of equipment.
- Provide all necessary inputs to the Qualifications Group for IQ/OQ/PQ of new equipment and facility.
- As the responsibility of a Computer System Validation (CSV) administrator, ensure the system is operating as per qualified requirements and maintained in a robust state while conforming to our change management system.
- To meet all deadlines associated with projects as directed, including all reports and documentation as directed.
- To keep the Director of Engineering up-to-date on project schedules.
- To conform to the principles of cGMP and to conform to all relevant departmental and other company standard operating procedures.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values and demonstrates a strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Bachelor's degree or higher in Chemical/Electrical Engineering, or Technologist
- Minimum 7 years of experience in the design/build/programming troubleshooting and maintenance of control systems.
- Professional Engineer licensed or in the process of being licensed
- Familiar with GMP, FDA, ISO requirements and Validation concepts and protocols.
- Strong PLC and HMI programming skills; must have proven hands on experience in PLC/HMI logic programming and troubleshooting systems in a pharmaceutical or biopharmaceutical manufacturing facility.
- Strong knowledge of process control and machine automation in pharmaceutical manufacturing facility.
- Understanding of cGMP software quality system principles and sanitary equipment design requirements.
- Working knowledge of word processing, spreadsheet, and database management software. Cad design would be an added benefit.
- Strong communication skills.
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Senior Automation Engineer - Whitchurch-Stouffville, Canada - Teva Pharmaceuticals
Description
The opportunity
We are currently seeking a Senior Automation Engineer to join our team.
This is an onsite role, located in Stouffville Ontario.
Responsibilities will include but are not limited to:
Your experience and qualifications