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Manufacturing Process Specialist
3 months ago
Overview
As a key member of the Product Launch and Sustaining team, the Manufacturing Process Specialist is tasked with enhancing operational efficiency and effectiveness by developing and implementing essential tools aimed at improving the manufacturing and production scalability 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 activities for existing products.
Key Responsibilities
The Manufacturing Process Specialist will actively engage in the development and execution of master validation plans to ensure timely product launches and qualification of new equipment. 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 comprehensive process validations (PV/PQ).
- Engage in risk management activities related to new or modified products or processes in accordance with ISO 14971.
- Utilize risk assessments to inform testing strategies for process validations.
- Identify process limitations and establish specifications to define release criteria.
- Resolve nonconformances that arise during the manufacturing of both new and existing products.
- Assist in design transfer, particularly during the later phases of product or process launches into manufacturing.
- Recognize process improvements and lead initiatives for their successful implementation.
- Support studies and scientific documentation necessary for regulatory approval.
- Develop product and manufacturing specifications during product development to ensure a seamless transition of new designs to production.
- Scale up research and development processes to high-volume production levels.
- Facilitate the setup of contract manufacturers, collaborating with them to develop new processes and manufacturing specifications, while overseeing their validations.
- Apply Six Sigma methodologies to analyze data for process performance and monitoring requirements.
- Conduct gap analyses and support initiatives for regulatory transitions.
- Communicate complex technical information clearly to research personnel and colleagues in other departments, including Manufacturing, Quality Assurance, Regulatory Affairs, and Sales & Marketing.
- Assist in the research, planning, and evaluation of alternative methods and testing procedures.
Qualifications
To be successful in this role, 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 4 years of industry experience with a proven track record in a GLP, GMP, or similarly regulated environment.
- Experience in process validation utilizing industry-standard methods for IQ, OQ, and PQ.
- Experience with design and technology transfer activities for medical devices, pharmaceuticals, or closely related manufacturing processes.
- Strong understanding of statistical analysis for testing and process validation.
- Familiarity with ISO 13485 and ISO 9001 standards.
- Excellent interpersonal, oral, and written communication skills.
- The ability to work independently after a brief period of specific technical training.
- Strong analytical and technical writing capabilities.
- Proficiency in computer skills, including MS Office, Access, and Excel.
- Organizational skills and attention to detail.
What We Offer
We provide a competitive compensation package, which includes:
- Comprehensive health benefits, including dental coverage fully funded by the employer.
- Flexible working hours.
- Paid sick leave.
- A bonus day off with pay on your birthday each year.
- Access to a full-size in-house fitness gym and shower facilities.
- Reserved parking at no cost.
- The opportunity to collaborate with industry experts who are passionate about their work.
- A vibrant company culture with opportunities to engage in social activities.
- A chance to be part of a culinary culture in our large kitchen.
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. The company has received numerous local and industry accolades, reflecting its commitment to innovation and excellence.
Join us in our mission to make a meaningful impact on millions of lives.
