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.