GMP Validation & Equipment Engineer I

cGMP Consulting Inc.; Illinois; On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting is seeking a motivated entry‑level engineer/scientist to support engineering activities for equipment, utilities, facilities, systems, and processes in a GMP environment. This role offers hands‑on exposure and growth in validation projects under supervision.

The ideal candidate has a basic understanding of cGMP and FDA guidelines, strong technical writing, and the ability to work with limited supervision in a fast-paced manufacturing setting in Lake Forest, IL.

Qualifications

• Bachelor's degree in Engineering, Science or related field.
• 0–2 years’ experience in a GMP manufacturing environment preferred.
• Experience in technical writing including drafting SOPs, protocols, and reports is preferred.

Responsibilities

• Assist in setup, testing, and daily operation of new processes, equipment and systems with Engineering teams.
• Perform validation and qualification tasks for equipment, utilities, cleaning procedures, computer systems, and/or new products.
• Execute validation/qualification studies, including protocol prep and final report documentation.
• Support deviation investigations by data collection, reporting, and supplemental qualification activities.
• Author SOP updates and revisions related to processes, equipment and system modifications.

Skills

Critical thinking

Technical writing

Protocol execution

SOP updates

Data collection

Microsoft Word/Excel

Education

Bachelor's degree in Engineering/Science

Job description

cGMP Consulting is seeking a motivated entry‑level engineer/scientist to support engineering activities for equipment, utilities, facilities, systems, and processes in a GMP environment. This role offers hands‑on exposure and growth in validation projects under supervision.

The ideal candidate has a basic understanding of cGMP and FDA guidelines, strong technical writing, and the ability to work with limited supervision in a fast-paced manufacturing setting in Lake Forest, IL.