Process Engineer

Amneal • Piscataway, NJ

7h

About The Position

Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.

Responsibilities

• Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
• Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.
• Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements
• Coordinate/oversee the development of new processes or troubleshoot existing ones
• Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits
• Initiation of Change Controls and Planned Deviations when required

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed