Validation Engineer II: Cleanroom Smoke Studies Expert

Advantage Technical; Woodstock (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Advantage Technical seeks an experienced Validation Engineer II to support qualification and validation activities in a sterile pharmaceutical manufacturing environment. You will plan, execute, and document smoke studies in Grade A–D cleanrooms and develop robust validation protocols with clear acceptance criteria.

The role involves coordinating with Engineering, Manufacturing, QA/QC, Regulatory Affairs, and other teams.

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 3+ years of validation experience with a bachelor’s degree (2+ years for Master’s).
• Smoke studies in Grade A–D cleanrooms.
• Strong knowledge of FDA/CGMP guidance for aseptic environments.
• Experience in sterile pharmaceutical/biologics environments.
• Knowledge of cGMP and validation principles.
• Experience developing validation protocols and final reports.

Responsibilities

• Plan, coordinate, execute, and document smoke studies in Grade A-D areas.
• Develop validation protocols with clear specifications and acceptance criteria.
• Evaluate study results and document observations, deviations, and conclusions.
• Support qualification of facilities, cleanrooms, equipment, utilities, processes, and controls.
• Act as validation representative on cross-functional project teams and lead when assigned.
• Research regulatory requirements for assigned validation activities.
• Schedule validation execution with Manufacturing, Engineering, QA, QC, and Regulatory Affairs.
• Prepare validation reports and documents summarizing results and compliance.
• Develop complex validation procedures and test methods with high accuracy.
• Prepare test plans for equipment changes and project activities.
• Provide validation support to Engineering, Manufacturing, QA, QC, and Regulatory Affairs.
• Assist in developing and revising validation SOPs and quality standards.
• Support inspections by internal, customer, and regulatory bodies.
• Collaborate with management and stakeholders to identify and manage risks.

Skills

Smoke studies

FDA requirements

Sterile environment

Validation principles

Independent work

Project management

Technical writing

Cross-functional work

Education

Bachelor’s degree in Engineering/Life Sciences/Physical Sciences

Master’s degree (optional)

Tools

Microsoft Office

Job description

Advantage Technical seeks an experienced Validation Engineer II to support qualification and validation activities in a sterile pharmaceutical manufacturing environment. You will plan, execute, and document smoke studies in Grade A–D cleanrooms and develop robust validation protocols with clear acceptance criteria.

The role involves coordinating with Engineering, Manufacturing, QA/QC, Regulatory Affairs, and other teams.