The Process Engineer III implements process improvements to meet quality standards, performs feasibility studies, solves problems, and creates necessary documentationin Agile and SAP environments and they aide in communication to personnel.
Provides technical process ownership to core manufacturing processes, further improves and develops process methods, systems, and support infrastructure to optimize production rates, efficiencies, yields, costs and quality performance.
Supports manufacturing department and SAP operations by creating master recipes, issues quality notifications, processes non conformances
Analyses manufacturing, product, and process data to improve products and to monitor processes
Participates KAIZEN events, conducts Gemba walks, 5S s, R3 s or PSSR s.
Ensuring planned engineering (process) progress with respect to the process engineering deliverables, process engineering planning & scheduling, preparation of progress reports, utilization of resources effectively & efficiently.
Provides operational leadership by managing design calculations, Process Optimization, sizing & selection of equipment etc. Review of specifications, datasheets, installation, start-up and validation of new or improved process equipment and technologies.
Interacts with customers, internal team members and vendors to develop process and equipment specifications. Prepares qualification reports, flow diagrams, and charts on research data and information.
Implements and maintains appropriate engineering records consistent with cGMP and ISO regulations for production of Life Science biochemicals and reagents.
Work closely with engineers/production staff. quality staff to monitor and improve the efficiency, output and safety of the plant
Analyze downtime to identify chronic/sporadic failures and lead reliability improvement efforts. Making observations and taking measurements directly, as well as collecting and interpreting data from the other technical and operating staff involved.
Lead RCA (Root Cause Analysis) and performs PFMEA s of processes to identify root cause and implement corrective actions to prevent recurrence ensuring that all aspects of an operation or process meet specified regulations.
Development and utilization of key reliability metrics to consistently measure performance.
Support manufacturing and maintenance efforts as needed by the operation.
Manage multiple projects as deemed necessary based on requirements.
Develop new manufacturing processes and assess the adequacy of equipment to meet ever changing market/manufacturing demands.
Identifies new equipment and technologies to support continuous improvement and capacity expansion of core capabilities. Design, validate and commission new production equipment and tooling, monitor modifications and upgrades, and troubleshoot existing processes.
Develops project budgets associated with the procurement of new equipment and technologies.
Performs other duties as assigned.
Education:
Bachelors degree in Chemistry, Chemical Engineering or related field.
Experience:
Minimum of 7-10 years of working experience in a manufacturing environment, in an engineering capacity involving chemical manufacturing, scale up and site transfer, process design, NPI process for manufacturability; hands on involvement required.
Experience in Agile and waterfall project management, Pilot and Production transfers and their requirements are required.
Proficiency using SAP Hana ERP module required.
Fluency in manufacturing operations, Project management and Kaizen experience.
Knowledge of basic problem-solving tools (DMAIC), Six Sigma and lean manufacturing concepts, 5S.
Familiarity with NuSil processes and products is strongly desired.
Additional Qualifications:
Knowledge of process production activities in a chemical manufacturing environment.
Applied engineering experience in a GMP manufacturing environment preferred.
Advanced Excel skill, ability to write macros and generating pivot tables and graphs preferred.
Must possess excellent communication and problem solving skills, be detail oriented, and flexible to work on multiple projects simultaneously.
Proficiency in Microsoft Suite, Visual Basic, CAD and/or Solid Works preferred.
Knowledge of OSHA, NFPC, HazWoper, and other governmental regulatory requirements (e.g., 21 CFR Part 820, cGMP, ISO, FDA, etc.)preferred.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
