Job Description

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, support utilities, upstream, and downstream processes. Owner\'s engineering support is required for various upstream and downstream process equipment, critical and support utility systems. The chosen individual will be the engineering point of contact for the system/equipment they are responsible, providing technical oversight and accountability during design, construction and CQV . Cheme Process Engineers are technical experts in their field that are capable of designing, implementing, and testing engineered solutions in the pharmaceutical and biotechnology field. The successful candidate has proven experience delivering capital projects for clients. The duties for the role include but are not limited to the following:

• Primary engineering point of contact with client for systems/equipment that individual is responsible for
• Review of selected equipment, components, and instrumentation to ensure they meet client standards and integrate with existing systems
• Review and identification of process and equipment system boundaries
• Review of engineering calculations and equipment sizing
• Review of P&IDs, layout drawings and general arrangement drawings
• Review of engineering specifications including user requirements specifications, functional specifications, and detailed design specifications
• Review of Equipment Data Sheets
• Review of Equipment Utility Requirements
• Review of BIM Models
• Review and approval of shop drawings
• Review of commissioning and qualification protocols
• Support risk assessments associated with safety and quality
• Support Startup and Execution during the CQV phase
• Preparation of reports
• Oversight and coordination of equipment installation and start-up
• Field troubleshooting at the client site
• Working at the client sites

• Bachelor of Applied Science degree in engineering from a recognized Canadian university
• 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)

• Mechanical, Chemical, Process engineering skills with at least 5 years of current work experience in a similar capacity.
• Experience in the execution of engineering tasks including:
  • Process engineering calculations, equipment sizing, specifications, flow diagrams and P&ID\'s.
  • Design engineering of mechanical piping, skids, components and layouts
• 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)
• Experience in the following technical areas of vaccine manufacturing:
  • Critical Utilities
    • Water for Injection Generation and Distribution
    • Clean Compressed Air Generation and Distribution
    • Clean Generation and Distribution
  • Media & Buffer Preparation
  • Washing and Sterilization
  • Upstream
    • Fermentation & Incubation
  • Downstream
    • Disc Stack Centrifugation
    • Ultracentrifugation
    • Tangential Flow Filtration
    • Sterile Filtration
  • Clean-in-Place
  • Support UtilitiesWaste water (neutralization, bio-decontamination)
• Training and development of junior staff
• Proficiency in written and spoken English with the ability to communicate clearly with clients.
• Adept at dealing with client\'s and other people in a professional and courteous manner.
• 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.

• 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