Automation Specialist/Sr. Specialist

GCBT Green Cross biotherapeutics - Saint-Laurent, QC (30+ days ago)

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Position Summary

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

Qualifications:

  • 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

Language:

  • English (Required)
  • French (Required)