Process Engineer I

Process Engineer I

Location: Richmond, BC, Canada

Department: Product Launch and Sustaining

Position: Permanent, Full-Time

Reports to: Director, Scientific Affairs (day-to-day direction from senior process engineering team)

ABOUT BIOLYTICAL

bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail's Fastest Growing Companies list in 2020. We have been named Lifesciences BC's Growth Stage Med Tech Company of the Year and have been featured on BC's Fastest Growing Companies six years in a row. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team.

Come join us on our journey and help make a difference to millions of lives!

SUMMARY

As a member of the Scientific Affairs team, the Process Engineer I provides hands-on support to process development, validation, and manufacturing scale-up activities for bioLytical products. Working under the direction of senior process engineering staff, the Process Engineer I executes validation protocols, collects and summarizes process data, and assists with troubleshooting and continuous improvement efforts across production processes.

The incumbent will work to established protocols and procedures and will take on increasing independence and scope as competency is demonstrated. Decisions on validation strategy, acceptance criteria, and project direction rest with senior engineering staff and the Director, Scientific Affairs.

CORE VALUES

• INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes initiative on projects.

• NEVER SAY NEVER : Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.

• SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.

• TAKES OWNERSHIP of goals, decisions, actions and results: Arrives on time and prepared, leads by example, follows through on commitments.

• NSPIRED to excel: Demonstrates passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings and the business.

HOW YOU WILL CONTRIBUTE

Validation and qualification support

• Execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for equipment and processes under the direction of senior engineering staff

• Draft sections of validation protocols and reports for review and approval by senior engineers

• Set up and run validation and process studies, record observations accurately, and maintain complete and legible documentation in accordance with GDP requirements

• Compile validation data packages and assemble supporting evidence for review

Data collection and analysis

• Collect, organize, and summarize process and equipment data from routine production and study activities

• Perform routine statistical calculations (e.g. capability, variability, trending) using established methods and templates

• Prepare tables, charts, and summaries that support conclusions drawn by senior staff

Process support and improvement

• Assist with troubleshooting of production process issues by gathering data, running follow-up trials, and documenting findings

• Participate in investigations and root cause analysis activities as a contributing team member

• Identify and propose opportunities for process improvement based on observations and data

• Support design transfer activities by assisting with equipment set-up, trial runs, and documentation

Documentation and training

• Draft and revise standard operating procedures, work instructions, and forms under supervision

• Maintain accurate records within the quality management system

• Assist with the delivery of training to laboratory and manufacturing personnel on new or revised procedures

General

• Track and report progress on assigned tasks and deliverables

• Work collaboratively with Production, Quality, and R&D colleagues

• Comply with all company health and safety and quality system requirements

• Other duties as assigned

WHAT YOU WILL BRING

• Bachelor's degree in engineering, preferably biomedical, chemical, mechanical, or a related life science discipline

• 1 to 3 years of relevant experience; recent graduates with co-op, internship, or capstone experience in a regulated manufacturing or laboratory environment are encouraged to apply

• Exposure to or coursework in process validation (IQ/OQ/PQ) principles, with a willingness to learn industry-standard methods

• Familiarity with regulated environments (GLP, GMP, ISO 13485, ISO 9001) an asset

• Working knowledge of basic statistical concepts and comfort applying them to process data

• Strong technical writing skills and attention to detail in documentation

• Good interpersonal and communication skills; able to take direction and ask questions

• Able to work independently on assigned tasks following training and orientation

• Proficiency with MS Office (Excel in particular)

• Organized, methodical, and comfortable in a hands-on laboratory and production environment

WHAT WE OFFER

• A competitive compensation package

• Extended health benefits including dental, optometry, RMT, etc.

• Flexible working hours

• Paid vacation

• Bonus day off with pay on your birthday every year!

• Paid sick days

• Complimentary reserved parking

• Structured mentorship and a clear development path toward Process Engineer II

• Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun

• A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques

• The opportunity to join an 'off the charts' foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table