Senior Process Engineer

Responsibilities

• Identify and implement improvements and new technologies to processes to increase productivity, improve quality and reduce costs.
• Lead API process equipment troubleshooting efforts along with coordinating other support groups to return equipment to service.
• Serve as a Subject Matter Expert (SME) and lead API product/process failure investigations, implementing corrective actions, and preparing sound scientific reports.
• Author and provide technical support for developing new processes and equipment documents including URS, DOE’s, and validation documents.
• Author and/or review change control submissions to ensure the validated status of equipment is maintained.
• Review, monitor and trend operating data, consistently apply operational excellence and continuous improvement skills/tools in evaluating the data, and issue related reports and recommendations for maintaining and improving process reliability.
• Provide operations support to both the Cyclotron and Strontium Chemistry departments as needed.

Requirements

• Bachelor’s degree in chemical engineering or related field required.
• 5+ years of experience working as an engineer in an FDA regulated, GMP facility.
• 2+ years of manufacturing experience; preferably in the manufacturing of API and/or finished pharmaceuticals.
• 3+ years of experience working with particle accelerators, including operation, troubleshooting and maintenance.
• Experience preferred in the following areas: Ion-exchange chromatograph; LabView; Electroplating; small (volume), high value API production batches.
• Verifiable knowledge of and experience in application of cGMP’s, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.
• Experience in applied knowledge of necessary behaviors and techniques associated with pharmaceutical production.
• Knowledge of current industry practices and technologies.
• Proven experience in supporting and optimizing processes and equipment, as well as leading small teams, groups or efforts relating to those activities.
• Experience applying formal Root Cause Analysis and problem-solving methodologies.
• Experience using SPC and other Operational Excellence methodologies; Lean and/or Six Sigma certification preferred.
• Experience with radioactive isotopes and radiation safety programs is required.
• Must achieve and maintain Class 1 radiation worker status.