Manufacturing Engineer - Scientist I

• Representing Operations in design teams for new and on market product design and development, design transfer, and market phases.
• Facilitating in defining project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering.
• Collaborating on the development and assuming full ownership at Production release of material specifications, manufacturing processes, test methods, analysis tools, work instructions, stability studies, and related acceptance criteria for new or on market product.
• Leading and assisting in sustaining engineering projects for improvement of manufacturing process, cleaning processes, stability methods, test methods, product specifications, process/test equipment/fixtures, analysis tools, and business systems.
• Identifying opportunities for process innovations.
• Developing product stability plans, protocols, and reports for the Stability Program.
• Facilitating the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints.
• Task-specific and change control training of manufacturing personnel.
• Supporting a Manufacturing/QC operation which may be a high complexity, high product mix, small/large run production environment with batch processing up to ~4000 Liters
• including standard and custom product lines encompassing critical organic synthesis intermediates, general purpose reagents, IVD system reagents, Public Health, Food Safety, and cellular analysis assay products.

• Bachelor's Degree Bachelors of Science (or advanced degree) in the field of Chemistry/Chemical Engineering, Microbiology, Life Sciences, Biomechanical Engineering.
• 5+ Years Minimum of 5 years reagent Operations experience in a relevant ISO 13485 and/or FDA regulated setting
• 2+ Years Minimum of 2 years’ experience servicing reagent Operations with process improvement, and/or sustaining engineering, and/or design transfer in a Life Sciences, Chemistry, Biomechanical Engineering, or Medical Technology field.
• 1+ Year Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities
• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Knowledge of Enterprise Resource Planning, including applied knowledge of engineering functionality
• Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control
• Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
• Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
• Proven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments
• Mathematics and statistics aptitude.
• Data analysis and technical writing aptitude.
• Excellent oral and written communication skills.
• Proficient in Microsoft Word, Excel, and PowerPoint programs.
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines

competitive salary and benefits package