Statistical Process Engineer Job in St Petersburg 33701, Florida Us

Catalent's 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 Statistician 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 Statistician 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

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.


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