The Project Manager will serve as an engineering/consulting technical lead and subject matter expert, including process performance monitoring and troubleshooting and the development and implementation of process improvement strategies. This work involves the application of considerable professional engineering knowledge and skills to the direction of a major engineering project as an ongoing program function. Duties may involve functional supervision; coordination and scheduling of subordinate technical staff and the coordination of program or project activities with other divisions of a department and/or clients. Assignments are broad in scope with the opportunity for the use of independent judgment.
Responsibilities
Provide subject matter expertise to key engineering projects.
Reviews engineering specifications for compliance with ordinances and engineering requirements.
Develops specifications, estimates and standards for engineering projects.
Create cleaning cycle development strategies for a variety of equipment including process vessels and lines, chromatography skid/column, UF/DF skid, centrifuge, glass/parts washers, and portable processing equipment.
Perform risk assessment and gap analysis for site cleaning programs.
Perform batch record review, including verifying calibration and in-process data.
Perform spray coverage testing, cleaning verification/validation swabbing, and risk sampling.
Perform piping design and flow calculations for CIP systems.
Perform commissioning and provide automation support for CIP systems, including PLC and SCADA/Delta V systems
A minimum of fourteen (14) years of pharmaceutical manufacturing experience.
Reviews engineering specifications for compliance with ordinances and engineering requirements.
Requirements:
BS degree or higher in chemical engineering or a related engineering or scientific discipline. Familiarity with cleaning of process equipment, including CIP cycle development and optimization, piping design, and fluid dynamics.
Familiarity with plant control software, including PLC and SCADA/Delta V systems.