1. Coordinate and guide the execution of the validation master plan.
2. Provide the relevant support for regulatory audits, submissions, and other auditor requests.
3. Develop and run test protocols.
4. Develop and write commissioning, qualification, and validation documents.
5. Maintain validation documentation through the validation lifecycle.
6. Assist in validation support on the installation of any new equipment.
7. Troubleshoot in the event of abnormal testing results or issues identified by other staff members.
8. Ensure accurate records of all validation activities.

1. Troubleshoot new and existing packaging problems involving designs, materials and processes and provide creative, timely, and cost-effective solutions.
2. Analyze engineering drawings and specifications of product to determine physical characteristics of item, special handling, environmental and safety requirements, and types of materials required for packaging.
3. Work closely with global suppliers, engineering, product management, operations, and sourcing.
4. Identify and implement cost saving initiatives related to packaging materials, labor, efficiency, transportation, and storage.
5. Work with the manufacturing department to ensure that the packaging designs are optimized for manufacturability.

The duties described above are not inclusive. Additional duties may be permanently assigned or required from time to time due to the need to respond to customer needs and remain competitive in the marketplace. 

Minimum Knowledge, Skills, and Abilities Required

Work environment characteristics described here are representative of those that must be met by a Team Member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. A bachelor’s degree in Mechanical, Industrial or Packaging Engineering or equivalent.
2. Minimum of 3 years’ process validation experience.
3. Minimum of 1 years’ packaging testing experience.
4. Excellent documentation bias.
5. Attention to detail and analytical thinking.
6. Ability to provide technical support to all engineering and provide support to manufacturing and implementation processes of product packaging.
7. Fluently speak, read, and write English.
8. Skilled in time management.
9. Skilled in multi-tasking.
10. Good administrative skills and ability to proofread for accuracy and spelling.
11. Demonstrated customer problem solving skills.
12. Ability to work with minimal supervision.
13. Ability to learn and perform primary functions of positions within department.
14. Ability to manage stress.
15. Ability to meet physical demands of the job which include but are not limited to walking; bending; pushing; pulling; sitting for extended periods of time at a desk using a computer, phone, and headset; and occasionally lifting and carrying items which may weigh up to 45 pounds.
16. Position spends approximately 50% of time moving about the production area including walking, standing, sitting, squatting, reaching, twisting, and leaning.
17. Vision and hearing must be within or correctable to within normal range.
18. Must work from the corporate office and be able to work on time on a regular basis during regular business hours. Must be available for evening/weekend work as needed.
19. While performing the duties of this job, the Team Member is exposed to production equipment at various times. The noise level in the work environment is usually moderate.