Job: Process Engineer

Jobing Description

Process Engineer

Department: Technical Services
Location: Smithfield RI
Job Code: 344


Description

100 Technology Way

Smithfield, RI 02917

401-233-1200/Fax: 401-233-1210

Job Description

Department: Technical and Clinical Manufacturing Services

Position: Process Engineer

Reports to: Sr. Process Engineer

Position Overview

The Process Engineer is responsible for ensuring that manufacturing processes perform predictably and continue to yield product that conforms to specification. The incumbent will monitor, track, and trend process performance and recommend corrective actions and process improvements as required to ensure acceptable productivity and quality.

Primary Responsibilities:

Develop database structure and means to maintain populated data from ongoing commercial and clinical manufacturing batch records and data historian(s). Develop and maintain control charts and reporting structure from database with query features. Develop standards for identification, reporting and investigation of out of trend events compliant with GMP quality assurance. Coordinate quarterly review of process and product data.

Identify and propose process improvements and debottlenecking actions, both within and improvement from validated process, from process trends.

Identify most probable root causes and perform product impact assessments for deviations and investigations. Serve as Subject Matter Expert during inspections by Health Authorities.

Serve as Manufacturing liason to assure that Manufacturing Process Work Instructions and Batch Records are written to assure maintenance of validated and filed process performance within control limits.

Skills and Abilities:

The ideal candidate will have excellent team leadership skills with an ability to inspire and draw from multi-discipline team members, drive to a goal and formulate a clear conclusion.

Excellent verbal and written communication skills are required.

The ability to clearly present and defend statistical data and technical approaches and decisions in both written and verbal form to internal and external partners must be demonstrated.

The incumbent must possess technical knowledge of biopharmaceutical unit operations in a GMP environment.

Qualifications:

B.S., M.S. or Ph.D. in Engineering or Scientific discipline. Chemical or Biochemical engineering is preferred.

0 10 years of relevant experience in a biopharmaceutical manufacturing environment is desired. Work experience and education will be considered in combination.

Statistical Process Control training, certification or education is desirable

Process Improvement training or certification is beneficial