Associate Process Engineer - Night Shift
Amneal
Summary
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.
Job description
Essential Functions
- Support 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
- 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.
- Supports technical services by troubleshooting activities in the operation department. Protocol review and Development process
- 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.
Additional Responsibilities
- Other duties that management may from time to time assign
- Write deviation and CAPA (Corrective action and preventive action)
- Assist review of process related documents
Requirements
- Bachelors Degree (BA/BS) Engineering, Pharmaceutics, Industrial Pharmacy, or related field - Required
- Master Degree (MS/MA) Engineering, Pharmaceutics, Industrial Pharmacy, or related field - Preferred
- 0-3 years experience in Engineering, Pharmaceutics, Industrial Pharmacy or Pharmaceutical Manufacturing
Benefits
- Health insurance
- Insurance benefits
- 401(k) matching
- Short-term incentive opportunity
- Performance-based award
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.