Process Engineer II

Job Description

Job Description

Summary :

The responsibility for this position includes performing advanced engineering calculations and analyses, and will take the lead position in the preparation, performance, and on-schedule completion of project work; participating in the Design of new Chemical Processes (small, medium and large scale) and Scale-up & Validation of Chemical Processes and accompanying test methods. Commissioning and qualification, and maintenance of the validated state of all direct impact chemical manufacturing systems for Medical GMP processes and ISO processes will be required. This is a position which will require detailed knowledge of chemical processes and experience in validating them.

Key Duties and Responsibilities :

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Design Process Flow Diagrams, Material Balances, and Process & Instrumentation Diagrams.
• Size process equipment for distillation.
• Create functional (control) descriptions for all engineered systems.
• Provide analysis results in an effective form (written, marked up drawings, sketches, spreadsheets, presentation, as required) on work performed.
• Provide man-hour & material estimates for specific contract project tasks, and for entire internal projects.
• Participate in project team and client meetings, as needed.
• Monitor the work product of vendors, including schedule, budget, scope requirements, technical review and deliverables.
• Provide leadership and guidance in the preparation of Engineering Standards. Evaluate previous methodology and results to establish design factors, comparative values, and modify or create procedures.
• Participate in field assignments.
• Performs the necessary bench-scale reactions, purification, and solubility studies for the development of new chemical products or processes.
• Prepares transfer of technology documentation to support process development in production scale manufacturing.
• Assist with pilot scale manufacturing to support scale up of new manufacturing processes.
• Assists with developmental batches of new products in conjunction with manufacturing.
• Leads the Engineering aspects of IQ, OQ and PQ of new chemical processes and their hand-off to manufacturing staff.
• Other duties as assigned.

Qualifications, Education and / or Experience Required :

Language Skills :

Physical Demands :

Work Environment :

Other Duties :

AAP / EEO Statement :