Commissioning And Qualification Node Lead

Job Title:

Commissioning and Qualification Node Lead

Job Description

The Commissioning & Qualification (C&Q) Node Lead plays a pivotal role in leading and coordinating all C&Q activities within an assigned project node. This position serves as the primary interface between node execution teams and program-level leadership, ensuring that commissioning and qualification activities are strategically planned, executed, and reported in compliance with regulatory requirements and project schedules. The Node Lead provides day-to-day leadership across C&Q execution, pre-commissioning coordination, system handover, and performance reporting, while fostering a culture of safety, quality, and accountability.

Responsibilities

+ Serve as the primary point of contact for the C&Q Program Lead for all node-level C&Q activities.

+ Coordinate and oversee day-to-day C&Q execution within the node, ensuring alignment with program strategy and procedures.

+ 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 adherence to approved C&Q procedures, validation strategies, and regulatory expectations across all node activities.

+ Continuously identify opportunities to improve C&Q practices, driving efficiency while maintaining compliance.

+ Coordinate pre-commissioning activities in collaboration with mechanical, automation, and construction teams.

+ Review and accept Mechanical Completion (MC) packages from C&Q firms.

+ Coordinate punch list closeout activities with C&Q firms and SWAT teams.

+ Coordinate and support Factory Acceptance Tests (FATs) with vendors and construction managers within the node.

+ Ensure FAT outcomes are documented, communicated, and incorporated into execution planning.

+ Support and, where required, lead system handovers to User teams.

+ Ensure systems meet readiness criteria for qualification and operational use.

+ Provide regular reporting to C&Q Program Leadership, including progress and performance metrics, change management, planning, and resource forecasting.

+ Proactively identify risks and issues, recommending mitigation strategies.

+ Enforce a strong safety culture across all node activities.

+ Ensure all commissioning and qualification work complies with site safety requirements and industry best practices.

+ Promote safe work planning and execution in coordination with mechanical and construction teams, including Lockout/Tagout (LOTO) management.

Essential Skills

+ Strong leadership and coordination skills in complex, multi-discipline environments.

+ Deep understanding of commissioning, qualification, and validation life cycles.

+ Ability to manage multiple parallel activities while maintaining regulatory compliance.

+ Proactive problem-solver with a continuous improvement mindset.

+ 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 working knowledge of GMP, FDA, and industry standards for C&Q.

+ Demonstrated experience coordinating and leading C&Q execution at a system or node level.

+ Commitment to safety, quality, and disciplined execution.

Additional

Skills & Qualifications

+ Experience supporting mega capital expansion projects ($100M+).

+ Experience in API manufacturing facility commissioning, qualification, and validation.

+ Master's degree in Engineering or related discipline.

Work Environment

Onsite. Standard first shift hours, M-F.

Job Type & Location

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

Pay and Benefits

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

- Dental Plan - Vision Plan - Health Benefits - 401(k)

Workplace Type

This is a fully onsite position in Indianapolis,IN.

Final date to receive applications

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

About Actalent

Actalent 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 actalentaccom (%20actalentaccom)  for other accommodation options.