Upstream Process Engineer

Date:

 

Summary/objective:

The Upstream Process Engineer will be responsible for assisting Biopharmaceutical and FoodTech clients in their capital investment projects. This position works closely with our clients by structuring their projects from a process perspective and building relationships with them and other stakeholders.

More specifically, tasks will include process development assistance, process definition and mapping (Process Flow Diagrams), mass balances, technological transfers, process scale-up and facility layout development. The Upstream Process Engineer will also participate in the development of Capital expenditure evaluations and schedule preparation.

The individual will provide technical expertise and leadership to other process engineers by close collaboration with colleagues throughout the organization. He will evolve within multi-disciplinary project teams that includes mechanical engineers, automation engineers, architects, electrical engineers, regulatory specialists among others.

Qualified candidates need a minimum of 5 years of experience in an engineering role within the GMP-regulated biotech/pharmaceutical industry.

Responsibilities and Duties:

Located in the Greater Montreal area and reporting to the Process team director, the Upstream Process Engineer will support the process engineering requirements for client projects, including:

  • Develop conceptual, preliminary, and detailed designs, calculations, drawings and specifications.
  • Create & review block flow diagrams, PFDs, P&IDs, and Layout drawings.
  • Perform capacity simulation and analysis for process requirements.
  • Critically review engineering designs, test plans, and assess risks.
  • Prepare project schedules, scope statements and budgets.
  • Participate in the preparation of conceptual and basis of design reports.
  • 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.
  • 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 and internal and external presentations.

Basic Qualifications

  • Sc. or M.Sc. Degree in Chemical Engineering, Biochemical Engineering or related disciplines.
  • 5-7 years of progressive process engineering experience in the biotech/Food tech 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, cellular culture, 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.
  • Flexibility to travel to external manufacturing sites as needed for short periods of time.

Other Qualifications

  • Bilingual / knowledge of French language, both spoken and writing.
  • Expertise in late stage/commercial technology transfer, process characterization and process validation of gene therapy/viral vector manufacturing processes preferred.
  • Strong interpersonal and communication skills, verbal and written. Ability to speak effectively before groups of customers. Ability to communicate in a dynamic environment.
  • Knowledge of Stirred Tank Bioreactors, flat stock technology including Cellstacks, Hyperstacks and iCellis systems.
  • Downstream processing techniques and equipment in biologics.