Packaging Validation Engineer

cGMP Consulting Inc.; Melrose Park (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

An established industry player is seeking a motivated individual to support their Validation Department in pharmaceutical packaging. This role involves managing and leading projects that ensure compliance with FDA and industry standards. The ideal candidate will have a Bachelor's degree in engineering and experience in pharmaceutical manufacturing. You will be responsible for executing validation protocols, managing change controls, and driving projects from inception to completion. Join a dynamic team that values detail-oriented professionals and offers a comprehensive benefits package, including Medical, Dental, Vision, and 401K.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

401K Plan

Qualifications

• 2-5 years of experience in pharmaceutical manufacturing.
• Detail-oriented and able to work in a fast-paced environment.

Responsibilities

• Compose and execute validation protocols for packaging line equipment.
• Handle change control lifecycles and deviation investigations.
• Independently drive Packaging Engineering Projects.

Skills

Validation Protocols

Change Management

Root Cause Analysis

Project Management

Document Management Systems

MS Office Proficiency

Education

Bachelor's degree in Engineering

Tools

MS Office

Job description

Job Summary

This position is responsible for supporting the Validation Department to commission, qualify, and decommission pharmaceutical packaging equipment. The role involves leading, managing, and supporting various ongoing projects for clients in the pharmaceutical industry related to packaging engineering. Activities include document generation (IQ, OQ, PQ), change management (deviations and change controls), preparing project schedules, monitoring progress, communicating status, and ensuring successful project completion. Projects generally focus on client compliance with FDA and industry standards at various levels.

Responsibilities

1. Compose and execute validation protocols for packaging line equipment (IQ, OQ, PQ) as well as decommissioning protocols.
2. Research, develop, design, evaluate, document, and manage packaging line equipment, systems, materials, incoming receiving, and distribution systems.
3. Ensure compliance with applicable corporate and divisional policies and procedures.
4. Handle change control lifecycles and deviation investigations, including root cause analysis and CAPA activities.
5. Direct support personnel, coordinate, and report on project activities.
6. Investigate and evaluate existing technologies for potential improvements.
7. Review or coordinate vendor activities to support development and use.
8. Independently drive Packaging Engineering Projects for NPI and on-market products.

Position Skills and Requirements

• Bachelor's degree in an engineering field plus 2-5 years of related experience in pharmaceutical manufacturing.
• Highly motivated and independent individual.
• Detail-oriented and comfortable working in a fast-paced office environment.
• Experience with document management systems is preferred.
• Proficiency in MS Office, especially Word, PowerPoint, and Excel.

Compensation and Benefits

• Expected annual pay range: $70,000 - $90,000 USD.
• Benefits include Medical, Dental, Vision, PTO, and 401K.