This is an opportunity to join a thriving process engineering firm serving a wide range of industries from pharmaceutical and biologics to science and technology and food and beverage.

Cheme is a team of dedicated professionals that are passionate about what we do and how we do it. Cheme is a place where you will be challenged, supported, and given the freedom and ownership to thrive. We attract the best because we continually invest in our people through career planning, training and development, and mentorship. At Cheme we know that our business is successful when our clients succeed, and our clients succeed when our people reach their potential.

Cheme's client is working on the implementation of a new facility to expand vaccine manufacturing capability including critical utilities, upstream, and downstream processes. Technical support is needed for strategy development, protocol preparation, and execution for the commissioning, qualification, and validation of these processes.

Cheme Commissioning, Qualification, and Validation (CQV) Engineers combine their technical knowledge and expertise in GMP documentation to develop and execute the testing needed to bring critical utilities and processes into production.

The position will be based out of either of our offices : Campbellville, ON or Vaughan, ON.

This position for a one-year contract.

Typical job duties include but are not limited to the following:

• System Boundary Reviews
• Traceability Matrix Generation
• SOP Creation and Updates
• Validation Master Plans and Quality Plans
• Risk Assessments and Criticality Assessments
• Report Writing
• Vendor and Equipment Documentation Review
• Protocol Development and Execution
• Design Review and Design Qualification
• Factory Acceptance Testing
• Start-up/Shakedown Testing
• Site Acceptance Testing
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Travel to client sites as needed and support start-up and testing activities
• Identify system deficiencies, conduct root cause analysis, and develop potential solutions
• Identify and escalate project and safety risks
• Communicate effectively within the project team and with client stakeholders for documentation requirements

Requirements

• Bachelor of Applied Science degree in engineering from a recognized Canadian university
• Current registration with the Professional Engineers of Ontario as a licensed Professional Engineer

• Experience with Kneat electronic validation software is not mandatory but is considered a strong asset
• Ability to work under minimum supervision as part of a cross-functional team
• Excellent organizational and multi-tasking abilities
• Works well under pressure
• Excellent communication and interpersonal skills is a necessity
• Personable
• Written and oral communication excellence with the ability to speak concisely about technology
• Curious about different technologies and software and independent drive to become proficient
• Use of Microsoft operating system and Microsoft Office Suite to navigate a server environment and prepare engineering documents
• Valid driver's license, and owner of a car
• Multi-lingual (asset but not mandatory)

Core Competencies:

• At least 5 years of experience in commissioning and qualification of GMP systems in the pharmaceutical industry
• Ability to understand, verify and mark-up engineering design documents (P&IDs, electrical drawings, functional specifications, design specifications, etc.)
• Understanding of cGMP, GDP and regulatory requirements (FDA, Health Canada, EU) that govern the pharmaceutical/biotech industry
• Understanding of automated Process Control Systems (PCS), Distributed Control Systems (DCS), Manufacturing Execution Systems (MES), PLCs and Historian systems in a manufacturing setting. This includes HMI interfaces, process instrumentation, I/O's and ISA-88 batch control (strong asset but not mandatory)
• Understanding of validation using a risk-based approach as per ASTM E2500 Standards (asset but not mandatory)
• Exposure to one or more of the following utility or vaccine manufacturing processes:
  • Critical Utilities
    • Purified Water
    • Water for Injection
    • Clean Compressed Air
  • Media Preparation
  • Washing and Sterilization
  • Upstream
    • Fermentation
  • Downstream
    • Disc Stack Centrifugation
    • Chromatography
    • Ultracentrifugation
    • Tangential Flow Filtration
  • Clean-in-Place
  • Compounding
  • Filling and Packaging
  • Waste water (neutralization, bio-decontamination)

Benefits

• Extended Healthcare Plan (Medical, Disability, Dental & Vision)
• Paid Time Off Benefits
• Work From Home - Flexible hours
• Training & Development
• Bonus - Awards - Gifts
• Employee Assistance Program - Counseling