Associate Process Engineer - Night Shift

Night Shift – 12-hour per day, rotating schedule (6:00pm-6:30am): 3 days on week 1 and 4 days on week 2 of pay cycle.

Responsibilities

• Support process/validation engineer for plant operations to suggest and implement improvements; for new manufacturing processes through process and equipment validation, including completing process simulations, 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 execute equipment installation, operational qualifications, validation protocols, reports, and change controls.
• Support technical services by troubleshooting activities in the operation department, including protocol review and development.
• 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 in evaluating, improving, and validating current manufacturing practices or processes and equipment for continuous improvement toward 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 the possibility of material improvement.
• Write deviation and CAPA (Corrective Action and Preventive Action) reports.
• Assist in the review of process-related documents.
• Perform other duties as assigned by management.

Requirements

• Bachelor’s Degree (BA/BS) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field – Required.
• Master’s degree in Engineering, Pharmaceutics, Industrial Pharmacy, or related field – Preferred.
• 1 year or more of experience in Engineering, Pharmaceutics, or Industrial Pharmacy.

Pay

The base salary for this position ranges from $65,000 to $80,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.

Benefits

• Comprehensive, flexible, and competitive benefits program including above-market, diverse, and robust health and insurance benefits.
• Significant 401(k) matching contribution to help employees save for retirement.
• Programs to promote employee well-being, supporting work-life balance.