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
