Process Engineer

ZipRecruiter; Greater Toronto Area; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading engineering and consulting firm is seeking a Process Engineer specializing in Biotech. The role involves collaborating on various engineering projects, ensuring compliance with industry standards, and utilizing strong technical skills. Ideal candidates will have a degree in engineering and significant experience in the biotech sector.

Qualifications

• At least five years of experience in the biotech/pharmaceutical industry.
• Basic knowledge of upstream/downstream drug manufacturing.
• Proficiency in technical writing and software tools.

Responsibilities

• Lead client meetings to discuss technical issues and project updates.
• Coordinate with project management and clients during design and startup.
• Conduct engineering studies and prepare reports.

Skills

Technical writing

Automation engineering

Fluid flow modeling

Education

Bachelor’s or master’s degree in Mechanical, Chemical, Biochemical Engineering

Tools

Excel

PowerPoint

Visio

Word

SharePoint

Job description

Job Description

Process Engineer (Biotech)

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering Life Science Solutions, a Trinity Consulting Co., is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Located near San Francisco, California, with operations in the Eastern and Western US, Canada, and Singapore, ADVENT is involved in nearly every aspect of global pharmaceutical and biotechnology facility design, process engineering, and quality system projects.

Our services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, startup and commissioning, validation, and compliance consulting for leading biotechnology and pharmaceutical manufacturing companies.

The successful candidate will collaborate with a team of engineers engaged in designing, automating, commissioning, qualifying, and startup activities across various processes, systems, and facilities. We seek a candidate with strong technical aptitude, automation engineering skills, and technical writing abilities. This is an excellent opportunity to join our growing team!

Responsibilities

1. Lead or participate in client meetings to discuss technical issues, project updates, and progress.
2. Coordinate with project management, vendors, and clients during design, review, startup, and CQV of biopharmaceutical process and facility systems, including process equipment and utilities.
3. Review engineering design specifications, documentation, and drawings for upstream/downstream bulk processing equipment (fermenters, chromatography skids, bioreactors, TFF, UFDF, centrifuges, etc.) and utilities (WFI, process gases, etc.).
4. Ensure design reviews align with industry standards, best practices, cutting-edge technologies, and client requirements.
5. Develop load calculations, equipment sizing, system layouts, specifications, and coordinate process system interfaces.
6. Create and review process flow diagrams (PFDs), process and instrumentation diagrams (P&IDs), data sheets, and equipment/instrument specifications within a GMP environment.
7. Maintain a strong understanding of industry codes and standards (e.g., ASME BPE).
8. Conduct process engineering studies, prepare reports, and perform calculations.
9. Collaborate regularly with senior management and colleagues on technological advancements, lessons learned, and design techniques.
10. Participate in construction activities, including reviewing RFIs and submittals, responding to design change notices, site walk-throughs, and developing operational and acceptance tests.
11. Perform fluid flow and pressure modeling using advanced simulation tools.
12. Estimate utility requirements for new manufacturing processes and design utility distribution systems.
13. Conduct engineering studies for facility expansion, improvement, or automation projects with minimal supervision.
14. Own process-related aspects of projects and support the design team technically.
15. Build and maintain excellent relationships with clients and team members.
16. Demonstrate leadership abilities and capacity to work independently.

Qualifications

1. Bachelor’s or master’s degree in Mechanical, Chemical, Biochemical Engineering, or related fields.
2. At least five (5) years of experience in the biotech/pharmaceutical industry.
3. Basic knowledge of upstream/downstream drug manufacturing, fill/finish, packaging, and bulk processing equipment, including utilities (WFI, CO2, etc.).
4. Understanding of commissioning and qualification processes.
5. Experience in design or commissioning/qualification of systems such as upstream/downstream processing equipment, lyophilization, sterilization, Clean-In-Place, and utilities.
6. Strong skills in reading and understanding P&IDs and ISA symbols.
7. Knowledge of hygienic process components and instrumentation.
8. Basic familiarity with automation platforms (PLC/SCADA, DCS, BMS/BAS) is a plus.
9. Understanding of regulatory compliance (cGMP, OSHA, EPA, FDA) and familiarity with ICH and EMA guidelines is advantageous.
10. Proficiency in technical writing and software tools (Excel, PowerPoint, Visio, Word, SharePoint).
11. Willingness to travel within the USA as required.