Packaging Engineer - Pharma - Pharmaceutical Associates, Inc

PRIMARY PURPOSE or JOB SUMMARY

To provide engineering support to the manufacturing and packaging operational areas.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. To provide overall support in the safe and compliant manufacture and packaging of commercial pharmaceutical products.
2. Troubleshoot process and equipment issues during manufacturing and packaging. Assist maintenance technicians as needed during troubleshooting and repair.
3. Assist maintenance with parts management, preventative maintenance management and assist metrology with calibrations as needed.
4. Generate, edit and issue master batch documentation (MBR’s) for process, equipment and cleaning activities as needed.
5. Modify and maintain equipment and facility drawings as needed.
6. Investigate deviations and variances in both manufacturing and packaging that relate to equipment and process issues. Generate deviation reports and identify long term corrective and preventative actions. Assure implementation of such solutions in a timely manner.
7. Lead and assist in all technical process enhancements and ancillary activities such as but not limited to: Process and equipment validation, design, procurement, installation and startup of new equipment, changes to existing manufacturing process, etc.
8. Investigate and provide support for demonstration/scale up/pilot batch manufacture, engineering studies, equipment upgrades, etc.
9. Identify and suggest process and equipment improvements for Quality, Safety, efficiency and cost reduction in the operational areas. Execute projects accordingly.
10. Prepare and present training presentations for technical training of operations personnel.
11. Work in multi-functional teams (Validation, QA, QC, SCM) to enhance and facilitate overall operational success.

QUALIFICATIONS

Bachelor’s degree in Chemical Engineering, Pharmaceutical Science, Chemistry or other related discipline.

Previous experience working in a manufacturing or packaging organization is required. Pharmaceutical (cGMP) experience is strongly preferred.

Lean Six Sigma experience is recommended.

EQUIPMENT AND MACHINES

In depth understanding of liquid manufacturing equipment, qualified utilities and cGMP systems.

ADDITIONAL COMMENTS

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.