Production Engineering Consultant
4 weeks ago
Position Overview
As a vital member of the Product Launch and Sustaining team, the Manufacturing Process Specialist is tasked with enhancing operational efficiency and effectiveness through the development and implementation of essential tools aimed at optimizing the manufacturing and production scaling of bioLytical products. This role encompasses the creation and execution of validation plans for new equipment and processes, as well as overseeing design transfer activities for new products and supporting ongoing operations for existing offerings.
Key Responsibilities
The Manufacturing Process Specialist will actively engage in the development and execution of comprehensive validation plans to ensure timely product launches and equipment qualifications. This dynamic position presents daily challenges that require strong engineering principles and an agile approach.
- Formulate and implement process validation plans, protocols, and reports for equipment validations (IQ, OQ, PQ) and for end-to-end process validations (PV/PQ).
- Engage in risk management activities associated with new or modified products or processes in accordance with ISO 14971.
- Utilize risk assessments to guide testing strategies for process validations.
- Identify process limitations and establish specifications to dictate release criteria.
- Resolve nonconformities that occur during the manufacturing of both new and existing products.
- Assist in design transfer, particularly during the late phases of product or process launches into manufacturing.
- Recognize process enhancements and lead initiatives for their successful implementation.
- Support studies and scientific documentation necessary for regulatory approvals.
- Develop product and manufacturing specifications during product development to facilitate the effective transition of new designs to production.
- Scale up research and development processes to high-volume production.
- Collaborate with contract manufacturers to establish new processes and manufacturing specifications, overseeing their validations.
- Apply Six Sigma methodologies to analyze data and determine process performance and monitoring requirements.
- Conduct gap analyses and support initiatives for regulatory transitions.
- Clearly communicate technical and complex information to research personnel and members of other departments, including Manufacturing, Quality Assurance, Regulatory Affairs, and Sales & Marketing.
- Assist in research, planning, and evaluation of alternative methods and testing procedures.
Qualifications
Candidates should possess a Bachelor's or Master's degree in engineering, preferably in mechanical or biomedical engineering or a related life science field. A minimum of four years of industry experience is required, along with a proven track record in a GLP, GMP, or similarly regulated environment. Experience in process validation using industry-standard methods for IQ, OQ, and PQ is essential, as is familiarity with design/tech transfer activities for medical devices or related manufacturing processes.
What We Offer
We provide a competitive compensation package, comprehensive health benefits including dental coverage fully funded by the employer, flexible working hours, paid sick days, and a bonus day off on your birthday. Our facilities include a full-size in-house fitness gym and shower amenities, along with reserved parking. Join a team of industry experts who are passionate about their work and enjoy a vibrant company culture.
About bioLytical
bioLytical Laboratories Inc. is a privately-owned Canadian company dedicated to the research, development, and commercialization of rapid in-vitro medical diagnostics utilizing its proprietary INSTI technology platform. Recognized for its achievements, bioLytical has received several local and industry awards, reflecting its commitment to innovation and excellence.
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