Commissioning and Qualification (C&Q) Coordinator

Commissioning and Qualification (C&Q) Coordinator

Location: North Chicago, IL – Onsite

Contract: 12+ months duration with the possibility of extension

Work Schedule: Monday – Friday, five days a week, first shift

Automated Systems, Inc. is seeking an experienced Commissioning and Qualification (C&Q) Coordinator to support a $195M API Expansion Project with one of our global pharmaceutical manufacturing clients located in North Chicago, IL. In this role, you must have strong and proven expertise in project management, scheduling and coordinating in regulated manufacturing environments. Familiarity with pharmaceutical validation and cGMP principles is strongly preferred.

Position Overview

In this role, the C&Q Coordinator will manage the planning, scheduling, and execution of

activities to ensure facilities, utilities and equipment (FUE) and automation meet safety,

quality, and regulatory standards (cGMP) before production. The C&Q Coordinator will act as

the central link between engineering, validation, quality assurance (QA), and operations

teams to track milestones, manage documentation, and resolve project risks, ensuring all

systems are "right-first-time" and fully compliant.

Key Responsibilities

Project Planning & Scheduling: Develop and maintain detailed C&Q schedules, track project

milestones and adjust plans to meet changing demands. Specifically, the C&Q Coordinator will be

responsible for:

• Working directly with Project Manager(s) to develop an integrated schedule for all FUE and automation activities
  


• Maintaining and managing the tracking of validation workload and status
  


• Reporting of roadblocks
  

Cross-Functional Coordination: Act as the primary point of contact between the Project

Manager(s), engineering, construction, quality, and operations to align project priorities and

ensure readiness.

Compliance & Documentation: Ensure all activities adhere to cGMP, internal SOPs, and

regulatory requirements. As Change Owner of Project Change Record(s) in OneTrack:

• Author Local Project Change Record(s)
  


• Manage and maintain Local Project Change Record(s) and Change Action(s)
  

Execution Oversight: Monitor the status of commissioning and qualification activities, identify

risks or delays, and coordinate with vendors/contractors to maintain timelines.

Communication: Provide regular status updates (both written and verbally) to stakeholders and actively participate in the following forums:

• Validation Review Board (VRB) weekly forums
  


• Product Introduction Core Team Meetings
  


• Change Review Board (CRB) and Cross Functional Team (CFT) meetings for Change
  


• Control planning
  

Requirements

Qualifications

Education: Bachelor’s degree in engineering or a related scientific field, or equivalent

industry experience.

Experience: Minimum 5+ years of experience in validation, quality assurance,

pharmaceutical manufacturing, engineering, or project coordination.

Technical Knowledge: Familiarity with:

• FUE validation lifecycle (URS, DQ, IQ, OQ, PQ) requirements
  


• Basic knowledge of Automation CQV/Lifecycle requirements
  


• Risk-based C&Q strategies
  

Project Management Tools & Document Management Systems: Proficiency in

scheduling software such as MS Project or similar project tracking tools.

Experience working within electronic systems such as:

• OneVault (or equivalent document management platforms)
  


• OneTrack (or equivalent change management platforms)
  


• Kneat (or equivalent validation execution platforms)
  

Soft Skills: Strong leadership, analytical thinking, and effective cross-functional

communication skills to manage stakeholders and resolve conflicts.