Commissioning And Qualification Node Lead

We are hiring for a Commissioning & Qualification (C&Q) Node Lead to join our team. This role centers around leading and coordinating all C&Q activities within an assigned project node, acting as the primary interface between node execution teams and program-level leadership. The Node Lead will ensure commissioning and qualification activities are planned, executed, and reported in alignment with program strategy, regulatory requirements, and project schedules.

As the C&Q Node Lead, you'll provide day-to-day leadership across execution, pre-commissioning coordination, system handover, and performance reporting, all while promoting a culture of safety, quality, and accountability.

Key Responsibilities:

• Serve as the primary point of contact for node-level C&Q activities, coordinating execution and ensuring alignment with program strategy.
• Liaise with other Node Leads to manage cross-node dependencies, including shared utilities and temporary services.
• Develop and implement comprehensive C&Q strategies, execution plans, and schedules for your assigned node.
• Ensure adherence to approved procedures, validation strategies, and regulatory expectations, always seeking opportunities to improve efficiency and compliance.
• Coordinate pre-commissioning activities with mechanical, automation, and construction teams, handling utility priming, instrument calibration, automation downloads, consumable installation, and VFD setup.
• Review and accept Mechanical Completion packages, coordinate punch list closeout activities, and support Factory Acceptance Tests (FATs) with vendors and construction managers.
• Lead system handovers and ensure systems meet readiness criteria for qualification and operational use.
• Provide regular progress and performance reporting, including change management, look-ahead planning, critical path analysis, resource forecasting, and identifying risks with mitigation strategies.
• Enforce a strong safety culture and ensure all work complies with site safety requirements and industry best practices, including safe work planning and LOTO management.

Qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum of 5 years’ experience in commissioning and qualification, preferably within pharmaceutical or biotechnology environments.
• Working knowledge of GMP, FDA, and industry standards for C&Q.
• Demonstrated experience in coordinating and leading C&Q execution at a system or node level.
• Commitment to safety, quality, and disciplined execution.

Preferred Experience:

• Experience supporting mega capital expansion projects ($100M+).
• Familiarity with API manufacturing facility commissioning, qualification, and validation.
• Master’s degree in Engineering or a related discipline.

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

The pay range for this position is $105000.00 - $130000.00/yr.

- Medical Benefits include Vision and Dental options- Vacation and Paid time off plan- Paid Holidays- 401(k)

This is a fully onsite position in Indianapolis,IN.

This position is anticipated to close on Apr 7, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.