Process Engineer

SUN PHARMA; Chattanooga (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

SUN PHARMA in Chattanooga, TN is seeking an engineer to design and optimize manufacturing processes for intermediates and APIs. You will develop cost-effective solutions and lead cross-functional projects to improve efficiency, quality, and compliance.

Responsibilities include preparing and reviewing production instructions, overseeing batch records, validating calibrations, and training staff on API processes.

Qualifications

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

Responsibilities

• Prepare, review, approve and distribute production instructions for intermediates/APIs.
• Produce APIs/intermediates according to preapproved instructions.
• Review batch records to ensure completion and signature.
• Report and evaluate production deviations; investigate critical deviations.
• Ensure production facilities are clean and disinfected.
• Ensure calibrations are performed with proper records.
• Maintain premises and equipment with records kept.
• Review and approve validation protocols/reports.
• Evaluate proposed changes in product, process or equipment.
• Ensure that new/modified facilities and equipment are qualified.
• Review manufacturing needs, formulate solutions and implement process changes.
• Manage assigned projects to finish on time, under budget, within design parameters.
• Provide training for API processes.
• Other duties as assigned.

Skills

Presentation

Communication

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.