What are the responsibilities and job description for the Commissioning and Qualification Lead position at ACE Technologies, LLC?
At ACE Technologies, we work alongside pharmaceutical and biotech 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 Overview
We 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 Responsibilities
- Lead 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 Qualifications
- Experience: 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 Information
- Travel 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.
