Senior Process Engineer, Automated Visual Inspection

Senior Process Engineer, Automated Visual Inspection Summary

INCOG BioPharma is seeking a highly motivated individual with extensive capabilities in process engineering, manufacturing of injectable drug combination products and leading capital projects installing and qualifying automated visual inspection equipment. The ideal candidate must have experience in technical roles within biopharmaceutical based GXP manufacturing operations, including technology transfers, process/equipment validation and improvements for automated visual inspection systems.

The successful candidate will lead technical teams focused on automated visual inspection equipment to provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. The individual will have excellent oral/written communication skills with strong technical writing abilities. They will also have strong collaboration skills and be able to lead and/or participate in teams with internal partners, customers, and vendors.  Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment.

Essential Job Functions:

·       Leading the development of inspection recipes.

·       Installing, configuring, and calibrating vision systems (cameras, illuminators, lenses, image analysis software) on production lines.

·       Diagnosing and resolving hardware and software technical issues related to vision systems.

·       Optimizing vision system parameters to ensure accurate and reliable performance.

·       Defining inspection requirements and developing new vision applications.

·       Performing tests and validations on vision systems after maintenance or modifications.

·       Proven ability to drive activities for automated visual inspection equipment design, procurement. installation and validation. This includes maintaining strong cross-functional project teams and providing routine project updates to leadership.

·       Participate in continuous improvement projects aimed at optimizing inspection processes and reducing defects.

·       Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.

·       Participate in and support process FMEAs to understand process and product risks as a prerequisite for process validation.

·       Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.

·       Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.

·       Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.

·       Write and execute technical documentation (protocols & reports for equipment testing, recipe development, validation, and optimization of vision systems for varying types of product).

·       Work with vendors and suppliers to define requirements and understand functional specifications.

·       Understand manufacturing needs and adapt to the changing needs of the manufacturing environment.

·       Work flexible hours for the coverage of the production facility.

·       Mentor and train other team members.

Special Job Requirements:

·       Knowledge of data management tools and RCM.

·       Bachelor’s degree or higher in Chemical, Electrical, Biomedical or Mechanical engineering, Physics, Industrial Computer Science or related scientific field.

·       5+ years’ direct experience with AVI in biopharmaceutical or other GXP regulated industry.

·       Knowledge of the operating principles of vision systems and their related hardware and software components.

·       Ability to diagnose and solve technical problems, both hardware and software.

·       Knowledge of lighting techniques for industrial vision applications.

·       Ability to perform structured analyses supported by field data.

·       In-depth knowledge of visual inspection standards and practices.

·       Practiced with regulatory guidelines (FDA, EMA, ICH), capable of communicating compliance measures, and experience with regulatory inspections related to vision inspection.

·       Familiarity with vision system platforms like Keyence, Cognex or other comparable options.

·       Proficient with system lighting and