Validation Engineer – GMP Process & Equipment Lead

Actalent; Elgin (IL); On-site; USD 69,000 - 73,000; Full time

Benefits offered by this job

Contract-to-hire

Onsite in Elgin IL

Benefits package

Job summary

Actalent in Elgin, IL is seeking a Validation Engineer to author, execute, and maintain validation protocols, reports, and supporting documentation for manufacturing equipment and processes. You will support IQ/OQ/PQ, lead validation efforts, and collaborate with Quality, Manufacturing, Engineering, and Laboratory teams to drive compliant validation projects.

The role requires a Bachelor's in Engineering or related field, at least 2 years of validation in a regulated environment, strong

Qualifications

• Bachelor's degree in Engineering, Biology, Microbiology, Chemistry, Quality, or related scientific discipline.
• Minimum of 2 years of validation experience in a regulated manufacturing environment.
• Experience writing and executing validation protocols and reports.
• Experience supporting equipment qualification and process validation activities.
• Knowledge of FDA regulations and cGMP.
• Strong technical writing and documentation skills.

Responsibilities

• Author, execute, and maintain validation protocols, reports, and supporting documentation.
• Support equipment qualification and process validation activities including IQ/OQ/PQ.
• Lead validation efforts for manufacturing equipment, systems, and production processes.
• Support change control, deviation investigations, root cause analysis, and CAPA activities.
• Analyze validation data and prepare detailed technical reports.
• Partner with Quality, Manufacturing, Engineering, and Laboratory teams to support validation projects.
• Develop and maintain SOPs, validation master plans, process flow diagrams, and related documentation.
• Ensure compliance with FDA, cGMP, and internal quality requirements.
• Participate in validation activities associated with new equipment, process improvements, and product changes.
• Support audit readiness and continuous improvement initiatives.
• Prioritize multiple projects and manage competing deadlines in a fast-paced manufacturing environment.

Skills

Validation experience

Technical writing

Documentation skills

FDA regulations knowledge

Prioritization

Education

Bachelor's degree in Engineering or related field

Job description

Actalent in Elgin, IL is seeking a Validation Engineer to author, execute, and maintain validation protocols, reports, and supporting documentation for manufacturing equipment and processes. You will support IQ/OQ/PQ, lead validation efforts, and collaborate with Quality, Manufacturing, Engineering, and Laboratory teams to drive compliant validation projects.

The role requires a Bachelor's in Engineering or related field, at least 2 years of validation in a regulated environment, strong