Statistical Process Engineer
Technical Services department is responsible for the following:
· Production Plant Support (Maintenance, Optimization, Investigation, Root Cause Analysis) for Commercial Product Processes Transfer of New Products into the St. Petersburgh Site Project
· Management of Product Updates and New Product Introduction and Large Capitol Projects Process Analytical Technology Development and Implementation Development of Manufacture of Vegicaps® softgels
· The SPC Engineer provides support to Engineers and Scientists in the design of experiments and in data collection and analysis in support of QBD (quality by design) initiatives.
· The SPC Engineer also provides support to Statistical Process Control (SPC) and Process Analytical Technology (PAT) initiatives at the site.
· This position analyzes and interprets data from various sources.
· Compiles reports, charts, and tables based on established statistical methods.
· This position will provide support to Technical Services, Quality Control and Quality
Assurance in the following:
· Participate in Statistical Process Control Initiatives, Program Oversight, and Deployment
· Provides methods for automated data collection and reporting from Production Databases
· Aid Engineers and Scientists in the Design of Experiments (DOE)
· Development of Scientifically Valid Sampling Methodologies for studies, raw materials, and production in-process checks Evaluation of Test Data from Development Studies
· Evaluation of Production data as part of routine process monitoring
· Participate in Continuous Improvement Initiatives (Lean Six Sigma)
· Assist in Investigations and Provide Evaluation of Data where appropriate
· Must be capable of writing and or revising Standard Operating Procedures, Protocols and Test methods.
· Provides guidance/training to new and existing personnel in SPC, DOE, and Mathematical Methods Performs other miscellaneous duties as required.
· Work with minimal Supervision
Qualifications
Education and Experience:
· Requires BA or BS with college course work in mathematics; BS degree in Industrial Engineering or Computer Science is preferred.
· At least 3-5 years experience in a manufacturing environment employing SPC and DOE Previous work experience in a cGMP work environment preferred.
· Excellent training skills required Must possess good interpersonal skills.
· Ability to effectively communicate with co-workers.
· Excellent organizational skills required.
Knowledge/Skills Requirements:
· Experience with typical statistical software packages: SAS JMP, Minitab, Excel
· Must be able to type Experience in Data Acquisition from Databases (Oracle Experience Preferred); SQL scripting required
· Programming Languages: SQL required (Java, Python or Jython preferred; PHP a plus)
· Knowledge of data acquisition applications and databases
· Knowledge of Allen Bradley PLCs preferred
· Knowledge of SCADA systems (Inductive Automation, Iconics) and Electronic Batch Record Systems (Werum & POMS) preferred
· Experience in conducting and writing technical protocols and reports
Physical/Mental Requirements:
· Ability to work effectively under pressure to meet deadlines.
· Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
· Be accessible to manufacturing, laboratory and office staff. Be able to use required office equipment.
