Process Engineer, Manufacturing & Validation

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 65,000 - 80,000; Full time

Job summary

Amneal Pharmaceuticals is seeking an Associate Process Engineer to support operation leadership in implementing improvements, validation and automation for plant operations, including SOPs and process flow development.

You will assist in equipment qualification, data analysis, CAPA, root-cause analyses, and collaborate with cross-functional teams to ensure FDA/cGMP compliance and ongoing continuous improvement.

Qualifications

• Bachelor's Degree 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 in Engineering, Pharmaceutics, Industrial Pharmacy

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.
• 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.

Skills

Process optimization

SOP development

Education

Bachelor's Degree in Engineering/Pharmaceutics/Industrial Pharmacy

Master's degree in Engineering/Pharmaceutics/Industrial Pharmacy

Job description

Amneal Pharmaceuticals is seeking an Associate Process Engineer to support operation leadership in implementing improvements, validation and automation for plant operations, including SOPs and process flow development.

You will assist in equipment qualification, data analysis, CAPA, root-cause analyses, and collaborate with cross-functional teams to ensure FDA/cGMP compliance and ongoing continuous improvement.