C&Q Project Scheduler – Pharmaceutical Manufacturing

SOFT's client located in Indianapolis is looking for a C&Q Project Scheduler – Pharmaceutical Manufacturing for a long term contract assignment.
Our client is executing a large greenfield pharmaceutical manufacturing project in Indianapolis and is seeking a dedicatedC&Q (Commissioning & Qualification) Project Scheduler. This role will own and maintain the integrated C&Q schedule, ensuring alignment between construction, equipment installation, commissioning, qualification, and validation activities in a regulated GMP environment.Key Responsibilities

• Develop, maintain, and optimize a detailed integrated C&Q schedule covering systems turnover, commissioning, qualification, and validation milestones.
• Work closely with construction, engineering, CQV, QA/validation, and operations teams to collect progress data, dependencies, and constraints.
• Track plan vs. actual progress, forecast remaining durations, and provide regular schedule and progress reporting for C&Q workstreams.
• Identify critical path items and schedule risks impacting C&Q and mechanical completion, and recommend mitigation strategies.
• Coordinate sequence of system turnover packages, FAT/SAT, IQ/OQ/PQ activities, and GMP readiness in line with overall project milestones.
• Maintain schedule logic, calendars, and resource loading where applicable; support scenario analysis and re‑sequencing to accommodate changes.
• Support governance by ensuring schedules reflect regulatory, validation, and change‑control requirements typical for pharmaceutical projects.

Required Qualifications

• 3+ years of experience in C&Q scheduling or project controls on pharmaceutical, biotech, or medical device projects.
• Proven experience maintaining integrated C&Q schedules (plan/actual/forecast) using Primavera P6 or equivalent tools.
• Strong understanding of commissioning and qualification phases, including system turnover, protocol execution (IQ/OQ/PQ), and regulatory expectations for GMP facilities.
• Experience coordinating with CQV, validation, and QA teams on large, multi‑discipline projects.
• Excellent communication skills and ability to work on a high‑visibility, fast‑paced mega‑project with multiple stakeholders.

Preferred Qualifications

• Experience on large‑scale (>$1B) greenfield or major expansion pharma projects.
• Background in engineering, construction management, or project controls within life sciences.
• Familiarity with FDA, EMA, and other regulatory expectations for qualification and validation of pharma manufacturing assets.