Commissioning And Qualification Node Lead

Job Title: Commissioning and Qualification Node Lead

Job Description

The Commissioning and Qualification (C&Q) Node Lead leads and coordinates all commissioning and qualification activities within an assigned project node in a regulated pharmaceutical environment. This role serves as the primary interface between node execution teams and program-level leadership, ensuring that all C&Q work is planned, executed, and reported in alignment with program strategy, regulatory requirements, and project schedules. The C&Q Node Lead provides day-to-day leadership across C&Q execution, pre-commissioning coordination, system handover, and performance reporting, while fostering a strong culture of safety, quality, and accountability in a rapidly growing organization.

Responsibilities

• Serve as the primary point of contact for program-level C&Q leadership for all node-level commissioning and qualification activities.
• Coordinate and oversee day-to-day C&Q execution within the assigned node, ensuring alignment with approved program strategy, procedures, and validation approaches.
• Liaise with other C&Q Node Leads to manage cross-node dependencies, including shared utilities, temporary services, and wastewater discharge.
• Develop and implement comprehensive C&Q strategies, execution plans, and schedules for the assigned node.
• Ensure all node activities adhere to approved C&Q procedures, validation strategies, and applicable regulatory expectations.
• Continuously identify and implement opportunities to improve C&Q practices, driving efficiency while maintaining full compliance.
• Coordinate pre-commissioning activities with mechanical, automation, and construction teams, including utility priming, instrument calibration, automation downloads, installation of consumables such as filter cartridges, and VFD setup.
• Review and formally accept Mechanical Completion (MC) packages from C&Q firms, ensuring completeness and readiness for commissioning.
• Coordinate punch list closeout activities with C&Q firms and SWAT teams to drive timely resolution of outstanding items.
• Coordinate and support Factory Acceptance Tests (FATs) with vendors and construction managers within the node, ensuring outcomes are clearly documented and communicated.
• Incorporate FAT findings and outcomes into commissioning and qualification execution planning.
• Support and, where required, lead system handovers to User teams, ensuring smooth transition from project to operations.
• Verify that systems meet readiness criteria for qualification and operational use prior to handover.
• Provide regular reporting to C&Q program leadership, including progress and performance metrics, change management from initial scope, 2–4 week look-ahead planning, critical path analysis, and resource forecasting and constraints.
• Proactively identify risks and issues related to C&Q activities and recommend effective mitigation strategies.
• Enforce a strong safety culture across all node activities and ensure all C&Q work complies with site safety requirements and industry best practices.
• Promote safe work planning and execution in coordination with mechanical and construction teams, including effective Lockout/Tagout (LOTO) management.
• Maintain clear, structured communication with senior leadership, stakeholders, and execution teams regarding status, risks, decisions, and required actions.
• Champion continuous improvement, disciplined execution, and high standards of quality throughout all phases of commissioning and qualification.

Essential Skills

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum of 5 years of experience in commissioning and qualification, preferably in pharmaceutical or biotechnology environments.
• Strong leadership and coordination skills in complex, multi-discipline project environments.
• Deep understanding of commissioning, qualification, and validation lifecycles in regulated environments.
• Ability to manage multiple parallel C&Q activities while maintaining strict regulatory compliance.
• Strong working knowledge of GMP, FDA regulations, and industry standards for commissioning and qualification.
• Demonstrated experience coordinating and leading C&Q execution at a system or node level.
• Clear, structured communication skills with the ability to report status, risks, and decisions to leadership.
• Proactive problem-solving abilities with a continuous improvement mindset.
• Commitment to safety, quality, and disciplined execution in a pharmaceutical manufacturing context.
• Experience working within regulated environments such as pharmaceutical manufacturing.
• Technical experience engineering, commissioning, validation, and qualification.

Additional Skills & Qualifications

• Experience supporting mega capital expansion projects with total project values of $100M or more.
• Experience in API manufacturing facility commissioning, qualification, and validation.
• Master’s degree in Engineering or a related discipline.
• Experience working in pharmaceutical or biotechnology manufacturing environments.
• Familiarity with pharmaceutical manufacturing processes and operations.
• Ability to build strong working relationships with vendors, construction managers, and cross-functional project teams.
• Strong organizational skills and the ability to prioritize effectively in a fast-growing, project-driven environment.

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 21, 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.

Salary : $105,000 - $130,000