Commissioning and Qualification Lead

At ACE Technologies, we work alongside pharmaceutical companies to help bring their manufacturing projects to life. From consulting and project delivery to day-to-day operations, we specialize in commissioning, qualification, and validation—especially on large-scale capital projects. Our goal? To support the smooth launch of new manufacturing facilities. Our C&Q team works hand-in-hand with clients to make sure everything runs efficiently, meets regulatory standards, and delivers real results.Position OverviewWe are seeking an experienced Commissioning & Qualification (C&Q) Lead to oversee the commissioning and qualification processes for a major pharmaceutical manufacturing project in Lebanon, Indiana. This role offers a unique opportunity to contribute to the startup of a state-of-the-art facility as part of a team of C&Q experts delivering quality services to the industry.Key ResponsibilitiesLead C&Q Activities: Manage and execute the commissioning and qualification processes, ensuring compliance with GMP, FDA, and industry standards.Documentation Management: Develop, review, and approve critical C&Q documents, including Project Validation Plans, User Requirements IV and OV Test Plans and report summaries.Test Execution: Oversee and perform Installation Verification (IV) and Operational Verification (OV) test execution, ensuring accurate documentation and adherence to approved protocols.Team Leadership: Guide and mentor cross-functional project teams, providing expertise on validation practices and regulatory requirements.Continuous Improvement: Drive process evaluations and improvements to maintain alignment with project goals and regulatory standards.Stakeholder Engagement: Collaborate with equipment manufacturers, contractors, and internal teams to facilitate successful C&Q and start-up activities.​Minimum QualificationsExperience: At least 5 years in commissioning and qualification roles within chemical, oil and gas, pharmaceutical or similar environments.Education: Bachelor’s degree or higher in Engineering, Life Sciences, or a related field.Communication Skills: Exceptional ability to guide team members and influence cross-functional stakeholders.Project Management: Demonstrated capability to manage large, cross-functional projects independently.​Nice to have:Regulatory Knowledge: In-depth knowledge of FDA regulations and GMP guidelines. Additional InformationTravel Requirements: Ability to travel occasionally domestically and internationally for Factory Acceptance Testing (FAT).Work Schedule: Full-time, 40 hours per week.Work Environment: On site in Lebanon, Indiana and Indianapolis.