Process Engineer

6 days ago

Vaughan, Ontario, Canada Cheme Engineering Full time
Job Description

**About Cheme Engineering**

Cheme Engineering is a dynamic process engineering firm that serves a diverse range of industries, including pharmaceuticals, biologics, science and technology, and food and beverage. We are a team of dedicated professionals committed to excellence in our work, offering an environment where individuals are challenged, supported, and empowered.

**Job Summary**

We are seeking a highly skilled Process Engineer to join our team as an Equipment Specialist. The successful candidate will be responsible for executing engineering tasks, including sizing and selection of equipment, execution of engineering calculations, development of drawing and specification packages, preparation of capital budgets, and implementation of systems according to good manufacturing practices (GMP), good documentation practices (GDP), regulatory guidance requirements, and safety and environmental controls.

**Key Responsibilities**

  • **Serve as the primary engineering point of contact with clients** for assigned systems/equipment.
  • **Review and ensure compliance** of selected equipment, components, and instrumentation with client standards and integration with existing systems.
  • **Review and identification of process and equipment system boundaries**.
  • **Review engineering calculations, equipment sizing, P&IDs, layout drawings, general arrangement drawings, and equipment data sheets**.
  • **Review of engineering specifications**, including user requirements specifications, functional specifications, and detailed design specifications.
  • **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**.

**Requirements**

  • At least 5-7 years of experience in mechanical, chemical, process engineering, process development, or technology transfer.
  • Bachelor of Applied Science degree in engineering from a recognized Canadian / North American 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).

**Core Competencies**

  • Mechanical, Chemical, Process engineering skills with at least 5 to 7 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&IDs.
    • 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/biologics industry.
  • Understanding of automated Process Control Systems (PCS), Distributed Control Systems (DCS), Manufacturing Execution Systems (MES), PLCs and Historian systems in a manufacturing setting.
  • Understanding of validation using a risk-based approach as per ASTM E2500 Standards (asset but not mandatory).
  • 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.

**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.

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