Commissioning And Qualification Engineer II

Job Title: Commissioning and Qualification Engineer II

Job Description

The Commissioning and Qualification Engineer II is a mid-level engineering role tasked with independently executing commissioning and qualification activities while managing a defined project scope. This position builds upon the foundational skills developed at the Engineer I level, incorporating greater ownership of systems, direct client interaction, and leadership of small technical tasks or sub-teams. The Engineer II ensures deliverables meet both regulatory and client expectations, supporting project progress and team development.

Responsibilities

• Develop and execute commissioning and qualification (C&Q) protocols with minimal supervision.
• Take ownership of assigned systems or equipment within the project.
• Document test results, deviations, and resolutions with accuracy and compliance.
• Validate technical deliverables such as risk assessments, test plans, and summary reports.
• Review and provide feedback on documentation produced by C&Q Engineer I staff.
• Ensure all documents are compliant, audit-ready, and aligned with regulatory standards.
• Coordinate system-level C&Q activities with vendors, contractors, and clients.
• Contribute to project schedules, resource planning, and reporting.
• Escalate issues proactively and propose solutions to maintain progress.
• Apply risk-based verification and industry best practices (e.g., ASTM E2500, ISPE guidelines).
• Ensure execution complies with GMP, FDA, and client requirements.
• Support internal and client audits as required.
• Mentor and provide guidance to C&Q Engineer I team members.
• Contribute to knowledge transfer and training within the project team.

Additional Skills & Qualifications

• 2–5 years of experience in commissioning, qualification, or validation in pharma, biotech, chemical, or related industries.
• Bachelor’s degree in engineering or related technical field. Preferred degrees include Manufacturing Engineering, Chemical Engineering or Biotechnical Engineering
• Demonstrated ability to manage assigned systems or project scope independently.
• Familiarity with GMP, FDA, and industry guidelines (ASTM E2500, ISPE).
• Proficiency with validation and project management tools.

Work Environment

This is an onsite role with time split between a pharmaceutical manufacturing environment and an office environment. First Shift Hours (Monday - Friday).

This is a Permanent position based out of Indianapolis, IN.

The pay range for this position is $80000.00 - $100000.00/yr.

Medical insurance Vision insurance 401(k) Dental insurance

This is a fully onsite position in Indianapolis,IN.

This position is anticipated to close on Feb 10, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $80,000 - $100,000