Manufacturing Technology & Engineering (MTech) Position (full time)
Automation/Production Engineer
The current available full-time position is for a motivated and self-directed Automation Engineer/Scientist to join the MTech team within the department of Manufacturing.
As a member of the MTech team, the incumbent will play a key role in the development, procurement and implementation of automated manufacturing processes and equipment in support of Microbix QAP's and VTM business objectives. In addition, the successful candidate will also play a critical role in technology transfer and training of new automated production processes to the Manufacturing department, as well as provide continued troubleshooting support and technical expertise on an ongoing basis to ensure the continuity of Microbix strategic business operations. This position reports to the Manager - MTech.
Scope of work:
Apply engineering methods and principles towards designing and sizing of automated manufacturing processes for sterile fill and finish of liquid and swab materials (medical devices).
Develop and implement automated testing processes to enhance the efficiency and accuracy of R&D and QC workflows.
Take an active and hands-on leadership role in sourcing, purchasing, and installation of automated equipment for testing and fill and finish production processes.
Work within the requirements of an ISO 9001 and 13485 quality system, with a focus on equipment IQ/OQ/PQ.
Design and execute experiments to automate testing and manufacturing processes (e.g., automating biological assays, determining the liquid fill precision and accuracy of automated dispensing equipment).
Design and execute experiments to determine the cap/vial application and removal torque of automated capping equipment.
Apply statistical analysis to data to determine manufacturing process boundaries and tolerances.
Actively participate in the technology transfer of new automated production processes to the end-user (e.g. Quality Control, Manufacturing) departments.
Provide ongoing troubleshooting and technical support to the various departments on new and existing production processes.
Review various bioprocess unit operations (filtration, centrifugation, bioreactors etc.) used in manufacturing production campaigns and offer insights, recommendations, and drive changes to improve consistency, robustness, and yields.
Collaborate intra- and interdepartmentally (e.g. Manufacturing, Quality Control, Quality Assurance and Sales) on various projects.
Prepare technical reports, scientific presentations and tech transfer documents as required.
Write/revise batch production records and standard operating procedures as needed.
Education
University degree in mechanical, industrial or chemical/biochemical engineering or a relevant industrial science.
Advanced degree (M. Sc./M.Eng.) is preferred.
A minimum of 2-3 years of relevant industry experience is required.
Required qualifications/skills:
Strong mechanical/process engineering aptitude with prior exposure to workflow automation.
Hands-on experience with automated equipment for testing of biologicals and sterile fill and finish in the biotechnology/pharmaceutical industry.
Experience in the design and development of industrial testing and fill and finish processes.
Knowledgeable in upstream and downstream bioprocessing, comprising multiple unit operations.
Experience in procurement, commissioning, installation and troubleshooting of automation equipment.
Computer programming knowledge is required.
Experience in using statistical methods for the evaluation and interpretation of data.
Experience using AutoCAD or other design software.
Experience in technology transfer is an asset.
Experience in executing equipment and process validation.
Excellent communication skills, both written and verbal, with the ability to collaborate with all levels both inside and outside the organization.
Demonstrated ability to work under tight deadlines and manage multiple priorities.
Detail-oriented with a demonstrated ability to bring tasks to completion.
Lean Six Sigma training and/or certification is considered a strong asset