Associate Process Engineer

Amneal India • Piscataway, NJ

11h • $65,000 - $80,000 • Onsite

About The Position

The Associate Process Engineer provides support to the operation Manager/Associate Director Operation/ Engineering in implementing improvements, validation and automation to the plant operations and assist in several functions such as writing standard operating procedures (SOPs), develop process flow, review design documents related to procurement of new equipment. Help with equipment validation.

Requirements

• Bachelor's degree in Engineering or related field.
• Familiarity with process simulations and optimization studies.
• Knowledge of statistical and analytical tools.
• Understanding of FDA regulations and cGMP requirements.
• Ability to troubleshoot and perform root cause analysis.
• Experience with equipment installation and operational qualifications.
• Strong written and verbal communication skills.
• Ability to collaborate with cross-functional teams.

Nice To Haves

• Experience in a manufacturing environment.
• Familiarity with process flow development.
• Experience reviewing design documents for new equipment procurement.

Responsibilities

• Support process/validation engineer for plant operations to suggest and implement improvements for new manufacturing processes through process and equipment validation.
• Complete process simulations and optimization studies and implement modifications and process installations at the manufacturing level.
• Support day-to-day manufacturing operations by monitoring process performance and identifying improvement opportunities.
• Assist in process optimization to improve yield, efficiency, quality, and equipment reliability.
• Analyze manufacturing data using statistical and analytical tools to drive data-based decision making.
• Help prepare and update Standard Operating Procedures (SOPs) and help execute equipment installation and operational qualifications, validation protocols, reports, and change controls.
• Support technical services by troubleshooting activities in the operation department.
• Help generate reports, charts, and tables based on established statistical methods to drive process enhancements.
• Investigate process deviations and non-conformances; perform root cause analysis (RCA) and support CAPA implementation.
• Assist process/validation engineer evaluate, improve and validate current manufacturing practices or processes and equipment’s with an effort for continuous improvement towards productivity, quality, reliability and consistency.
• Provide support on various manufacturing/engineering equipment uptime.
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality standards.
• Collaborate with cross-functional teams to support continuous improvement initiatives and regulatory readiness.
• Communicate with vendors on possibility of material improvement.
• Write deviation and CAPA (Corrective action and preventive action).
• Assist review of process related documents.

Benefits

• Equal Opportunity Employer status.
• Consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws.
• Reasonable accommodation for the application process or hiring process available upon request.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level