Lead Engineer, New Product Introduction Engineering

The Role:

The new product introduction engineering (NPIE) team has two primary internal customers R&D and Operations. For the NPIE team to be successfulboth internal customers must be equally supported.

The NPIELeadengineer accomplishes this core purpose by assisting R&D with the development of products or processes. As well as developing a comprehensive understanding of the new product and processes and what is required for operations to successfully manufacture the product. Culminating in the implementation of the new product in the operations facilities and subsequent transition of the product management responsibilities to operations.

In this role you will:

Initial Product and Process Development

• Partner with formulation scientists and other stakeholders to fully understand product and process requirements.

• Conduct hazard reviews for all aspects of new formulations and processes to proactively identify and mitigate potential risks.

• Create pilot scale procedures and provide training for pilot plant operators.

• Monitor the quality of pilot scale batches using statistical process control procedures investigate all non-conformances and implement corrective actions.

Ensure Product and Process Robustness

• Own the planning and execution of routine product evaluation studies to ensure a full understanding of the products characteristics.

• Responsiblefor identifying the need for and completion of non-standardexperiments to better understand and predict product performance improved manufacturing processes etc. and implementing these learnings into the manufacturing process.

• Summarize and present trial data to project stakeholders.

Scale-upofNew Products and Processes

• Lead the development of optimized manufacturing process designs for new product Introductions with an emphasis on all aspects of safety quality and production efficiency.

• Develop and manage project scope/success criteria completion of project deliverables project timelines with prompt issue resolutionto drive the predictable execution of assigned projects.

• Interface with a cross functional team at all levels of the organization including R&D Operations Quality Finance Legal and Procurement to efficiently complete assigned projects.

Traits webelieve make a strong candidate:

LeadEngineer candidates are expected to possess very strong technical skills and be capable of proactively identifying project goals and meeting them withlimitedinstruction or guidance.

• Resultsdrivenwith a strong work ethic and a high sense of urgency accountability and initiative.

• Possess a continuous improvement mindset with a high tolerance for ambiguity.

• Ability to manage multiple projects and deadlines with an ownership mentality.

• Comfortable with challenging ideas and professionallymanaging toa solution.

• Effective communicator both written and verbal.

• Business acumen with strong analytical skills.

• Comfortablegrowing building and strengthening work relationships.

• Whatarethe Position Specific Competencies

Phase Gate Project Management

• Experience owning projects of moderate size and complexity. For example projects timelines of more than 1 year requiring the management of internal and/or external resources.

• Experience using Accolade a plus.

Process Control

• Experience using statical process control 6-sigma certification is preferred.

• Experience performing root cause investigations and corrective actions using tools such as the 8D methodologies.

Process design

• Capable of proactively determining the process requirements necessary for the successful production of a product.

• Able to conceptualize a process design that considers all process requirements

• Capable of documenting manufacturing processes using process flow diagrams P&IDs

• Proficient in calculating fluid dynamics variables relevant to liquid handling systems

• Knowledgeable of process scaling factors

• Proficient specifying common liquid and solids handling equipment and documenting those specifications.

Education and Experience

• Bachelors Degree Chemical Engineering or related technical field required.

• Minimum 8years demonstrated experience in the chemical process semiconductor food or pharmaceutical industry with background in process development commercialization pilot plant quality scale up or manufacturing.

• At least5years ofmanufacturing process design defining equipment specifications system commissioning and qualification

• At least5years of project management experienceas the owner forprojectdefinitiontimelinesand deliverables.

• Demonstrated ability to manage projects and navigate ambiguity to successfully achieve objectives withlimitedinstruction or guidance.

• Exceptionalwritten andpresentationskills.

• Six Sigma DFSS or DMAIC GB and knowledge/application of related tools preferred.

Your success will be measured by:

• Ability to proactivelycreate and document aplanfor all aspects of your work.

• All key deliverables for the initiative should be included in the plan.

• Ensure there are sufficient resources as well as the correct resources to complete the plan.

• Clearly document the plan using tools such as Gantt charts project charters etc.

• Your effectiveness in carrying out the planned work.

• Proactively schedule and complete deliverables

• Effectively work with task owners to ensure they complete their obligations to the initiative following the project plan.

• Proactively identify roadblocks and quickly develop a plan to mitigate the roadblock

• Your ability to proactively identify and implement continuous improvements for the NPD related procedures.

• Translate high-level goals into a tactical plan for improvement.

• Enhance the teams processes and procedures by aligning with industry standards while also pioneering novel solutions.