Packaging Validation Engineer

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

Job summary

An established industry player is seeking a motivated individual to join their Validation Department. This role involves leading and managing various projects in pharmaceutical packaging engineering, focusing on compliance with FDA standards. The successful candidate will be responsible for document generation, project scheduling, and ensuring project completion. With a dynamic work environment, this position offers the chance to work on innovative projects that directly impact client success. If you have a background in engineering and a passion for the pharmaceutical industry, this opportunity is perfect for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off (PTO)

401K Plan

Qualifications

• 2-5 years of experience in pharmaceutical manufacturing.
• Proficient in MS Office, especially Word, PowerPoint, and Excel.

Responsibilities

• Compose and execute validation protocols for packaging line equipment.
• Handle change control lifecycles and deviation investigations.
• Drive Packaging Engineering Projects for NPI and On-Market.

Skills

Pharmaceutical Manufacturing Experience

Document Management Systems

MS Office Proficiency

Detail Oriented

Project Management

Education

Bachelor's Degree in Engineering

Job description

Job Summary

This position is responsible supporting the Validation Department to commission, qualify and decommission pharmaceutical packaging equipment. They will lead, manage, and support a variety of on-going projects for clients in the pharmaceutical industry related to packaging engineering. Position activities include document generation (IQ, OQ, PQ) and execution, change management (deviations and change controls), prepare project schedules, monitoring progress, communicating status, and ensuring successful project completion. Projects are generally associated with client compliance to FDA and Industry standards at various levels.

Responsibilities

• Compose and executevalidation protocols for packaging line equipment(IOQ, PQ, Commissioning protocols) as well as decommissioning protocols.
• Research, develop, design, evaluate, document and manage packaging line equipment, systems, materials, incoming receiving, and distribution systems.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Handle change control lifecycles and deviation investigations includingroot cause analysis and CAPA activities.
• Directs support personnel, coordinates, and reports on project activities.
• Investigates and evaluates existing technologies for potential improvement.
• Reviews or coordinates vendor activities to support development and use.
• Independently drive Packaging Engineering Projects for NPI and On-Market.

Position skills and requirements:

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

Compensation and Benefits

• Expected pay range per year: $70,000-$90,000 USD
• Expected benefits include: Medical, Dental, Vision, PTO, 401K