Onsite Validation Engineer for Manufacturing & QA

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

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Job summary

Actalent is seeking a Validation Engineer for contract-to-hire engagement in Elgin, IL. The role focuses on authoring, executing, and maintaining validation protocols, reports, and related documentation, while supporting equipment qualification and process validation across manufacturing lines.

The engineer will lead validation efforts, participate in change control and CAPA, analyze data, and prepare technical reports in collaboration with Quality, Manufacturing, Engineering, and Laboratory

Qualifications

• Bachelor's degree or higher in Engineering, Biology, Microbiology, Chemistry, Quality, or a related scientific discipline.
• 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.
• Ability to manage multiple priorities and adapt to changing business needs.

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

Technical writing

Documentation

Project prioritization

Adaptability

Communication

Education

Bachelor's degree in Engineering, Biology, Microbiology, Chemistry, Quality

Job description

Actalent is seeking a Validation Engineer for contract-to-hire engagement in Elgin, IL. The role focuses on authoring, executing, and maintaining validation protocols, reports, and related documentation, while supporting equipment qualification and process validation across manufacturing lines.

The engineer will lead validation efforts, participate in change control and CAPA, analyze data, and prepare technical reports in collaboration with Quality, Manufacturing, Engineering, and Laboratory