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
- Support commissioning, qualification, and validation activities for solid dose manufacturing and packaging equipment.
- Execute and assist with authoring validation protocols, including IQ, OQ, and PQ documentation.
- Support validation of packaging equipment used for bottling, labeling, capping, induction sealing, case packing, and related operations.
- Assist with qualification and lifecycle support of serialization and aggregation systems, including printers, cameras, scanners, vision systems, labelers, and line-level serialization controls.
- Work with Quality, Manufacturing, Engineering, Packaging, Maintenance, and Validation teams to support project execution and GMP compliance.
- Assist with change controls, deviations, investigation support, and CAPA-related activities as needed.
- Perform field verification activities, equipment walk downs, test execution, data collection, and documentation review.
- Ensure validation documentation is accurate, complete, and aligned with internal procedures and regulatory expectations.
- Support troubleshooting and resolution of validation issues encountered during protocol execution.
- Review equipment documentation, drawings, manuals, specifications, and vendor documents to support validation deliverables.
- Maintain compliance with GMP, FDA, and company quality system requirements.
- Support continuous improvement efforts related to validation execution, documentation quality, and packaging line performance.
Requirements
Education & Experience Requirements
- Bachelor’s degree in Engineering, Science, or a related technical field preferred.
- 3–5 years of experience in validation, quality, engineering, or GMP manufacturing support.
- Hands-on experience with equipment qualification and IQ/OQ/PQ execution.
- Familiarity with GMP documentation practices, change control, deviations, and CAPA processes.
- Strong attention to detail and ability to follow written procedures and protocols.
- Good written and verbal communication skills.
- Ability to work effectively in an onsite manufacturing environment with cross-functional teams.