Commissioning And Qualification Engineer II

Job Title: Commissioning and Qualification Engineer IIJob DescriptionThe Commissioning and Qualification Engineer II is a pivotal mid-level engineering role, responsible for independently executing commissioning and qualification activities while managing defined project scopes. This position builds on the foundation developed at the Engineer I level by taking on greater ownership of systems, engaging directly with clients, and leading small technical tasks or sub-teams. The Engineer ensures that all deliverables meet regulatory and client expectations, supporting both project progress and team development.Responsibilities Develop and execute commissioning and qualification protocols with minimal supervision. Take ownership of assigned systems or equipment within the project. Document test results, deviations, and resolutions with accuracy and compliance. 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 commissioning and qualification 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. Essential Skills 2-5 years of experience in commissioning, qualification, or validation in the pharmaceutical, biotech, chemical, or related industries. Bachelor's degree in Engineering or a related technical field, with preferences for manufacturing, chemical, or biotechnical engineering. Demonstrated ability to manage assigned systems or project scope independently. Familiarity with GMP, FDA, and industry guidelines, such as ASTM E2500 and ISPE. Proficiency with validation and project management tools. Work Environment This is position is onsite. First shift Monday- Friday.Job Type & LocationThis is a Permanent position based out of Indianapolis, IN.Pay and BenefitsThe pay range for this position is $80000.00 - $100000.00/yr.Medical insurance Vision insurance 401(k) Dental insuranceWorkplace TypeThis is a fully onsite position in Indianapolis,IN.Application DeadlineThis position is anticipated to close on Mar 7, 2026.About ActalentActalent 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 () for other accommodation options.

Created: 2026-03-10