Process Engineer- Pharma/Biotech

Company overview:

Laporte & Associates, through its subsidiaries, is an engineering firm specializing in the supply of process, building and utilities design services to the agri-food, beverage, biotech and pharmaceutical industry sectors. Laporte operates across Canada, the United States and Europe. The firm has experienced significant growth over the past several years and anticipates continuation of this growth.  For more information, visit our website: www.laporteconsultants.com

Process Engineer – Pharmaceutical / Biotech – Toronto, ON

Role Overview:

The Process Engineer will support pharmaceutical and biotechnology projects from conceptual and preliminary design through detailed engineering, procurement, construction support and commissioning. The position is intended for an engineer who can quickly become familiar with new or ongoing projects, take ownership of assigned process engineering work, and execute work with limited supervision while coordinating with the Process Lead, Project Manager, clients, vendors and other disciplines.

The role will primarily support active pharmaceutical/biotech projects involving clean utilities, sterile/fill-finish operations and process systems, while also supporting other engineering projects as needed.

Responsibilities and Duties:

• Review existing project documentation, client requirements, design basis, drawings and vendor information and quickly become familiar with projects already in progress.
• Execute process engineering work packages with limited supervision and raise technical issues, assumptions and decisions requiring Process Lead/client input.
• Prepare and update PFDs, P&IDs, process descriptions, utility flow diagrams, equipment lists, utility load summaries and design calculations.
• Perform mass and energy balances, equipment sizing, hydraulic/pressure drop calculations and utility capacity assessments.
• Support design of pharmaceutical clean utilities including WFI, purified water, pure steam, clean compressed air and other clean gas systems and distribution networks.
• Support sanitary process system design including tanks, pumps, heat exchangers, piping, valves, instrumentation, CIP/SIP systems and POU assemblies.
• Support pharmaceutical manufacturing and sterile/fill-finish systems, including formulation, filling and associated support equipment.
• Develop equipment and system specifications, datasheets, scope of work, and technical requirements for procurement.
• Review vendor P&IDs, general arrangements, equipment drawings, calculations, utility requirements, controls & instrumentation, and technical submittals.
• Assist with RFQs, technical bid evaluations, vendor clarifications, shop drawing reviews and procurement activities.
• Coordinate process requirements and interfaces with mechanical, automation, electrical, architectural, structural and CQV disciplines.
• Participate in design reviews, HAZOP/FMEA or other risk reviews where required.
• Maintain technical action lists, assumptions, open items and design decisions and communicate potential schedule, cost or technical impacts to the Process Lead/Project Manager.
• Support site surveys, construction activities, field reviews, commissioning, FAT/SAT and qualification activities as required.
• Support preparation of engineering proposals, scope definitions, preliminary calculations, equipment concepts and effort estimates for new projects.
• Work across multiple assignments as project priorities change.

Basic Qualifications:

• Bachelor’s or master’s degree in chemical engineering or a related engineering discipline.
• 3+ years of relevant process engineering experience in pharmaceutical, biotechnology, or other regulated life sciences industries.
• Experience in pharmaceutical/biopharmaceutical process design, with experience in clean utilities, CIP/SIP, and sanitary process systems and exposure to one or more of USP/DSP, formulation, fill-finish, or other pharmaceutical process equipment.
• Experience preparing and reviewing PFDs, P&IDs, process descriptions, equipment lists, utility load summaries, and process calculations.
• Practical experience with mass and energy balances, equipment sizing, hydraulic calculations, pressure drop calculations, and utility capacity assessments.
• Experience with clean utility systems, such as WFI, purified water, pure steam, clean compressed air, and other clean gases.
• Experience with sanitary process-system components including piping, valves, pumps, vessels, heat exchangers, instrumentation, and hygienic equipment.
• Ability to review and interpret vendor drawings, datasheets, equipment packages, P&IDs, utility requirements, and technical submittals.
• Familiarity with GMP design principles, ASME BPE, ISPE guidelines, and applicable pharmaceutical engineering standards.
• Working knowledge of AutoCAD and commonly used engineering software and tools, including Microsoft Excel, Word, PowerPoint, Visio, and Bluebeam Revu.
• Experience supporting equipment/system procurement, including technical specifications, RFQs, bid reviews, vendor clarifications, and shop drawing reviews.
• Ability to independently execute defined engineering work packages and quickly become familiar with ongoing projects, existing documentation, assumptions, and design decisions.
• Strong written and verbal communication skills and ability to coordinate effectively with clients, vendors, and multidisciplinary engineering teams.
• Ability to manage priorities and work on several concurrent projects or assignments.
• Willingness to travel to project and manufacturing sites as required.

Additional Experience Considered an Asset:

• Previous experience in an engineering consulting or EPCM environment.
• Experience supporting sterile manufacturing, formulation, fill-finish, or other pharmaceutical manufacturing areas.
• Experience reviewing and integrating OEM/vendor equipment packages into pharmaceutical facilities.
• Experience with FAT, SAT, commissioning, start-up, or qualification activities for process equipment or clean utility systems.
• Experience participating in design reviews, FMEA, HAZOP, or other technical risk assessments.
• Working knowledge of controls and automation interfaces, including instrumentation, sequences, alarms, and equipment interlocks.
• Familiarity with Revit, Navisworks, PIPE-FLO, or other 3D coordination/process calculation software is an asset.
• Eng. designation or eligibility for registration in Ontario is an asset.

Benefits – What We Have to Offer:

• Competitive Salary: Competitive salary commensurate with experience and industry standards;
• Health and Wellness Programs: Comprehensive group health insurance coverage from day one (medical, dental, vision, childcare);
• Retirement Plans: Employer-contributed RRSP plan at 4%;
• Flexible Work Arrangements: Hybrid work mode, with a minimum of 2 days per week in the office;
• Professional Development: A work environment that encourages empowerment and professional growth. Professional reimbursement fees (e.g., APEGA, APEGS, EGBC, etc…) covered by the company;
• Career Advancement Opportunities: Mentorship programs, training, cross-department opportunities, etc.;
• Work-Life Balance: 3 weeks of regular vacation with 1 week of paid vacation during the Christmas holidays. 1 week of Personal/Sick leave ;
• Inclusive Culture: A diverse, flexible, and non-conformist work environment that values equity, work-life balance, and promotes efficiency in daily tasks with enormous growth opportunities;
• Team-Building Activities: Lunch & Learn sessions, team retreats, outdoor activities, family get-togethers, and workshops;
• Other Benefits: Public transport and telephone reimbursement