The Automation Specialist/Sr. Specialist is responsible for ensuring that the materials used for GCBT's GMP activities/operations are sourced from qualified suppliers; and that these materials are qualified, inspected and released in full compliance with regulatory standards and Green Cross Biotherapeutics (GCBT) requirements.
Key Duties and Responsibilities
- Leads and implements the automation projects at GCBT throughout the project lifecycle in support of the site strategy for automation and instrumentation
- Oversees the programming of PLCS and automation controls
- Provides troubleshooting support for site controls and instrumentation, as well as technical support at the equipment/PLC level
- Serves as the site subject matter expert in technical discussions with internal stakeholders and outside vendors.
- Serves as the subject matter expert to support timely closure of quality system records associated with automation systems
- Owns and maintains the design and specifications for equipment and instrumentation
- Develops automation related SOPs and performs training for users of the systems
- Assists in establishing preventative maintenance requirements for related manufacturing systems and maintains computer configuration records (version control, back-ups and user access lists)
- Specification and documentation of user requirements and implementing requirements in a robust and efficient manner.
- Supports, oversees and executes programming, configuration, and integration of equipment
- Completes engineering/automation change controls for intended modifications to automation systems and programming
- Develops and executes commissioning test plans for automation changes
- Participates with the IT team in the development of the industrial computerized network
- Performs other duties as assigned by Head of Operations
- University Degree in Engineering (electrical, computer preferred).
- Specialist: 6 to 10 years in a related position / professional engineering role with 8 years preferred
- Specialist: Minimum 10 years in a related position / professional engineering role; supervisory experience preferred as the senior role may have a small team of direct reports and technicians
- Hands-on experience in programming PLC, HMI and SCADA systems
- Experience with Allen-Bradley, Siemens, Wonderware, Pi Historian automation platforms required
- Experience with Building Automation systems preferred
- Experience managing automation/control system projects throughout entire project lifecycle
- Excellent problem-solving and communication skills
- Demonstrated ability to work within a team environment
- Strong knowledge of and ability to interpret and apply the applicable, cGMP regulations (Canada and US), good engineering practices, and good automation manufacturing practices for the biotech industry.
- Detail-oriented, thorough and methodical with strong interpersonal, organizational and communication skills
- Able to trouble-shoot, be proactive and multi-task under strict deadlines
Job Type: Full-time
- English (Required)
- French (Required)