Formulation Engineer

Amneal • Piscataway Township, NJ

11d

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.

Requirements

• Sound pharmaceutical/engineering skills
• Independent judgment
• Ability to work as a team member
• Ability to educate internal partners on projects
• Ability to monitor and execute projects
• Effective and cooperative relationships with all departments within and outside the organization
• Ability to manage post approval projects
• Ability to analyze statistical data, products or functional specifications to determine conformance with standards and established quality requirements
• Ability to coordinate/oversee the development of new processes or troubleshoot existing ones
• Ability to assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA)
• Ability to assist in various audits
• Ability to initiate Change Controls and Planned Deviations when required

Responsibilities

• Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysis and 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 and established 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
• Career Level: Mid Level
• Education Level: No Education Listed