Associate Process Engineer - Night Shift

Amneal

16d•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. This role supports process/validation engineer for plant operations to suggest and implement improvements for new manufacturing processes through process and equipment validation. This entails completing process simulations and optimization studies and implementing modifications and process installations at the manufacturing level. The role also supports day-to-day manufacturing operations by monitoring process performance and identifying improvement opportunities, and assists in process optimization to improve yield, efficiency, quality, and equipment reliability. Analysis of manufacturing data using statistical and analytical tools is key to driving data-based decision making. The Associate Process Engineer will help prepare and update Standard Operating Procedures (SOPs) and assist in executing equipment installation and operational qualifications, validation protocols, reports, and change controls. They will support technical services by troubleshooting activities in the operation department and assist in protocol review and development. The role involves generating reports, charts, and tables based on established statistical methods to drive process enhancements, investigating process deviations and non-conformances, performing root cause analysis (RCA), and supporting CAPA implementation. Additionally, the Associate Process Engineer will assist the process/validation engineer in evaluating, improving, and validating current manufacturing practices or processes and equipment, with an effort towards continuous improvement in productivity, quality, reliability, and consistency. Support on various manufacturing/engineering equipment uptime is also a responsibility, ensuring compliance with FDA regulations, cGMP requirements, and internal quality standards. Collaboration with cross-functional teams to support continuous improvement initiatives and regulatory readiness, and communication with vendors on the possibility of material improvement are also part of the role. Other duties that management may from time to time assign, including writing deviations and CAPAs, and assisting in the review of process-related documents, are also included.

Requirements

Bachelors Degree (BA/BS) Engineering, Pharmaceutics, Industrial Pharmacy, or related field - Required
0-3 years experience in Engineering, Pharmaceutics, Industrial Pharmacy or Pharmaceutical Manufacturing

Nice To Haves

Master Degree (MS/MA) Engineering, Pharmaceutics, Industrial Pharmacy, or related field - Preferred

Responsibilities

Support process/validation engineer for plant operations to suggest and implement improvements.
Support new manufacturing processes through process and equipment validation, including process simulations and optimization studies.
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).
Help execute equipment installation and operational qualifications, validation protocols, reports, and change controls.
Support technical services by troubleshooting activities in the operation department.
Assist in protocol review and development.
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.