Job Description

Description:

The 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.

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