Senior Biopharma Process Engineer
The senior process engineer is responsible for overseeing and planning operations for our pharmaceutical and biopharmaceutical clients as well as develop processes to ensure quality, cost and efficiency requirements are met. The engineer will also serve as a resource and expert to the process engineering team. This position works closely with our Partners and clients in designing systems, troubleshooting problems with production, and taking corrective action and building relationships with clients and other stakeholders. Qualified candidates need a minimum of 10 years of experience in an engineering role within the biotech/pharmaceutical industry.
Responsibilities and Duties:
Located in the Greater Toronto Area and reporting to the Lead Process Engineer, the Senior Process Engineer will support and lead the process engineering requirements for client projects.
- Supervises and guides junior and intermediate process engineers for the successful delivery of the projects
- Develop and review conceptual, preliminary, and detailed designs, calculations, drawings, and specifications
- Create and review block flow diagrams, PFDs, P&IDs, and Layout drawings
- Perform capacity simulation and analysis for process and clean utility areas
- Write and review process & equipment specification documents for vendor and client packages
- Critically review engineering designs, test plans, and assess risks
- Prepare project schedules, scope statements and budgets
- Ensure that projects are implemented in accordance with the agreed scope and timelines and make relevant recommendations to the client
- Work collaboratively as part of multi-disciplinary design teams
- Chair project team meetings and provide technical direction
- Manage timely completion of tasks per plan without direct supervision
- Support project management requirements
- Provide discipline specific input for bid packages and tenders
- Suggest, contribute, and champion initiatives to improve the Engineering Department’s operations and procedures
- Support positive client interactions and sub-consultant interface
- Perform data analysis, prepare technical reports, SOPs, and internal and external presentations
- Pursue opportunities for business development and future growth of the organization across various local geographies
- Sc. or M.Sc. Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Industrial Engineering, or related fields.
- 10+ years of progressive process engineering experience in the biotech/pharmaceutical industry.
- Experience in the design of fluid and bulk materials handling processes including preparation of process flow diagrams, heat and material balances and P&IDs,
- Knowledgeable about unit operations within pharma/biopharma industries including fermentation, purification, formulation, clean utilities, biological confinement.
- Familiarity with pharmaceutical regulations (FDA, ICH Guidelines, ISPE, and best industrial practices).
- Knowledgeable about current industry standards for the design and construction of pharma and biopharma facilities, such as ASME BPE and ISPE Guidelines.
- Experience in the design of sanitary process systems including piping, vessels, and CIP/SIP systems.
- Able to work on multiple projects and meeting timelines in a fast-paced environment. Proven problem-solving abilities.
- Experience with MS Office products especially Word, Visio and Excel required.
- Working knowledge of drawing tools such as AutoCad.
- Flexibility to travel to external manufacturing sites as needed.