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 GC 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