Process Engineer

Sun Pharmaceutical Industries, Inc.; Chattanooga (TN); On-site; USD 75,000 - 95,000; Full time

Job summary

A global pharmaceutical company located in Chattanooga, Tennessee is seeking an experienced Chemical Engineer to provide engineering designs and recommendations for manufacturing processes. The ideal candidate will have at least 5 years of experience with FDA/GMP regulations and a degree in Chemical Engineering. Responsibilities include preparing production instructions, managing projects, and ensuring compliance with industry standards. This role requires strong problem-solving skills and the ability to train teams effectively.

Qualifications

• 5 years experience with FDA/GMP regulations.
• Skills in presenting ideas effectively to management.
• Familiarity with DEA guidelines preferred.

Responsibilities

• Prepare and approve production instructions for APIs.
• Produce intermediates and ensure compliance with records.
• Evaluate production deviations and administer corrective actions.
• Review changes in products and processes for optimization.

Skills

Process optimization

Technical documentation

Project management

Training

Education

BS in Chemical Engineering

Job description

This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost effective solutions for manufacturing.

Job Duties

• Prepare, review, approve and distribute the instructions for the production of intermediates or APIs, according to written procedures.
• Produce APIs and intermediates according to preapproved instructions;
• Review all production batch records and ensure that these are completed and signed.
• Report and evaluate all production deviations and ensure that all critical deviations are investigated (with the conclusions recorded).
• Ensure that production facilities are clean and disinfected;
• Ensure that all necessary calibrations are performed (with records kept)
• Maintain the premises and equipment (with records kept).
• Ensure that validation protocols and reports are reviewed and approved;
• Evaluate proposed changes in product, process or equipment.
• Responsible for ensuring that new and modified facilities and equipment are qualified.
• Review and analyze manufacturing needs, formulate solutions and implement changes to optimize manufacturing processes.
• Manage assigned projects in order to complete each project on time, under budget and within the design parameters.
• Provide training for API processes.
• Other duties as assigned.

Education, Experience & Competencies

• BS in Chemical Engineering.
• 5 years experience with FDA/GMP. Experience with DEA guidelines and regulations a plus.
• Ability to present ideas effectively to all levels of management.