HVAC Design Engineer for Biotech Facilities

at  Pharmeng Technology Inc

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
We are seeking an experienced HVAC Design Engineer to serve as the primary engineering point of contact for assigned systems/equipment in biotech facilities based in Toronto, Ontario. The ideal candidate will have a strong background in HVAC design, engineering calculations, and equipment sizing, as well as experience in commissioning and qualification protocols.

REQUIREMENTS:

• Mechanical, Chemical, or Process engineering skills with at least 6 to 10 years of current work experience in a similar capacity.
• 7+ years in HVAC design for biotech facilities with ISO 8 design standards.
• Experience in 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/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.
• Familiarity with 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 clients and other people in a professional and courteous manner.
• Proficient in using 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.

• Review and ensure the compliance of selected equipment, components, and instrumentation with client standards and integration with existing systems.
• Review and identify process and equipment system boundaries.
• Review engineering calculations, equipment sizing, P&IDs, layout drawings, general arrangement drawings, and equipment data sheets.
• Review engineering specifications including user requirements specifications, functional specifications, and detailed design specifications.
• Review BIM models and approve shop drawings.
• Review commissioning and qualification protocols.
• Support risk assessments associated with safety and quality.
• Support startup and execution during the CQV phase.
• Prepare reports and oversee equipment installation and start-up.
• Perform field troubleshooting at client sites.
• Work at client sites as needed.