Equipment Validation Engineer - Solid Dose Manufacturing & Packaging

Job Description
Equipment Validation Engineer - Solid Dose Manufacturing & Packaging

Location: Gurnee, IL - Onsite

Contract: 6+ Month Contract with Strong Potential for Extension

Automated Systems, Inc. is seeking a Junior Equipment Validation Engineer to support one of our pharmaceutical manufacturing clients at their Gurnee, IL solid dose manufacturing and packaging facility. This site primarily supports the manufacturing and packaging of tablets, capsules, and powders, with a strong focus on bottling operations, packaging equipment, and serialization systems.

This is an excellent opportunity for a validation professional with approximately 3-5 years of experience who is looking to grow in a hands-on GMP manufacturing environment. The successful candidate will support equipment qualification, protocol execution, documentation, change control, and validation activities associated with solid dose production and packaging operations.

Key Responsibilities

• Supportcommissioning, qualification, and validation activities for solid dosemanufacturing and packaging equipment.
• Executeand assist with authoring validation protocols, including IQ, OQ, and PQdocumentation.
• Supportvalidation of packaging equipment used for bottling, labeling, capping,induction sealing, case packing, and related operations.
• Assistwith qualification and lifecycle support of serialization and aggregationsystems, including printers, cameras, scanners, vision systems, labelers,and line-level serialization controls.
• Workwith Quality, Manufacturing, Engineering, Packaging, Maintenance, andValidation teams to support project execution and GMP compliance.
• Assistwith change controls, deviations, investigation support, and CAPA-relatedactivities as needed.
• Performfield verification activities, equipment walk downs, test execution, datacollection, and documentation review.
• Ensurevalidation documentation is accurate, complete, and aligned with internalprocedures and regulatory expectations.
• Supporttroubleshooting and resolution of validation issues encountered duringprotocol execution.
• Reviewequipment documentation, drawings, manuals, specifications, and vendordocuments to support validation deliverables.
• Maintaincompliance with GMP, FDA, and company quality system requirements.
• Supportcontinuous improvement efforts related to validation execution,documentation quality, and packaging line performance.

Requirements

Education & Experience Requirements

• Bachelor'sdegree in Engineering, Science, or a related technical field preferred.
• 3-5years of experience in validation, quality, engineering, or GMPmanufacturing support.
• Hands-onexperience with equipment qualification and IQ/OQ/PQ execution.
• Familiaritywith GMP documentation practices, change control, deviations, and CAPAprocesses.
• Strongattention to detail and ability to follow written procedures andprotocols.
• Goodwritten and verbal communication skills.
• Abilityto work effectively in an onsite manufacturing environment withcross-functional teams.