As a member of the Product Launch and Sustaining team, the Process Engineer is responsible for supporting the drive for operational efficiency and effectiveness by developing and implementing tools critical for improving manufacturing and production scale up of bioLytical products, including creating and executing validation plans for new equipment and processes, design transfer activities of new products, and supporting sustaining activities for existing products. This support may include product improvement implementation, supporting non-conformity investigations and mitigations, implementing material changes, etc. You will act as a technical expert and provide mentorship to elevate the knowledge of those you work with. This position reports to the Manager, Product Launch and Sustaining.
The Process Engineer II will play an active role developing and executing master validation plans in order to launch new products and qualify new equipment on time. With this, this fast-paced role will provide daily challenges that should be tackled with strong engineering principles and an agile mindset.
HOW YOU WILL CONTRIBUTE
- Develop and execute process validations plans, protocols and reports for equipment validations (IQ, OQ, PQ) and for end-to-end process validations (PV/PQ)
- Participate in risk management activities related with new or modified products or processes following ISO 14971
- Use risk assessments to drive testing strategy for process validations
- Determine process limitations and define specifications to drive release criteria
- Troubleshoot to resolve nonconformances that arise during manufacture of new and current products
- Support design transfer, particularly for late phase of launching products or process into manufacturing
- Identify process improvements and lead activities required for their effective implementation
- Support studies and scientific documentation for regulatory approval
- Develop product and manufacturing specifications during product development to ensure the successful transfer of new designs to production
- Scale up R&D processes to high volume production processes
- Support the setup of contract manufacturers, working in partnership with them to develop new processes and manufacturing specification, and oversee their validations
- Use Six Sigma methodology to analyse data to determine process performance and monitoring requirements
- Conduct gap analysis and support initiatives for regulation transition, e.g. IVD to IVDR
- Provide technical and complex information clearly to research personnel as well as to members of other departments including Manufacturing, Quality Assurance, Regulatory Affairs, and Sales & Marketing
- Support research, planning and evaluation of alternate methods and testing procedures
WHAT YOU BRING
- Bachelor’s or Master’s degree in engineering, preferably mechanical or biomedical engineering or related life science
- Minimum 4 years’ industry experience and a track record of working in a GLP, GMP, and/or similarly regulated work environment
- Must have process validation experience using industry standard methods for IQ, OQ and PQ
- Must have experience with design/tech transfer activities for medical devices, pharma or other highly related manufacturing processes
- Strong knowledge of statistical analysis for testing and process validation
- Knowledge of or experience with ISO 13485, ISO 9001
- Excellent interpersonal skills, oral communication skills, and written communication skills
- Must be able to work independently following a brief period of specific technical training
- Must have strong analytical and technical writing skills
- Excellent computer skills (MS Office, Access, Excel)
- Organized and detail-oriented
WHAT WE OFFER
- A competitive compensation package
- Extended health benefits including dental - 100% employer contribution
- Flexible working hours
- Paid sick days
- Bonus day off with pay on your birthday every year!
- Full-size in-house fitness gym and shower facilities
- Complimentary reserved parking
- 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
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!
- INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the 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.
- INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.
Job Type: Full-time