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Process Engineer at Amneal India

Piscataway, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Mar, 26

Salary

0.0

Posted On

12 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Cleaning Validation, Data Analysis, Statistical Analysis, Cross Functional Coordination, Troubleshooting, Root Cause Analysis, Corrective Actions, Preventative Actions, Change Controls, Deviations, Audits, Project Management, Pharmaceutical Engineering, Team Collaboration, Quality Standards

Industry

Pharmaceutical Manufacturing

Description

Description: 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. Essential Functions: 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 Additional Responsibilities: Initiation of Change Controls and Planned Deviations when required

Responsibilities

The Process Engineer plans, executes, and directs validation assignments and projects, ensuring compliance with quality standards. They also manage post-approval projects and coordinate with cross-functional teams.