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ExaTech Inc · 1 day ago

Commissioning and Qualification (C&Q) Project Manager

Conshohocken, PA

Contract

Onsite

Senior Level

ExaTech Inc is seeking a Commissioning and Qualification (C&Q) Project Manager to develop and execute the project’s C&Q strategy. The role involves overseeing the C&Q team, ensuring compliance with regulatory standards, and managing project activities to deliver successful outcomes.

Human ResourcesInformation TechnologyStaffing Agency

Hiring Manager

Hari Goud

Responsibilities

Develop and implement a risk-based C&Q strategy for all GMP (direct impact) and non-GMP (indirect impact) systems and assets, aligned with current industry practices

Provide input across all project phases, including design, construction, operational readiness, and technical operations

Lead and manage a team of approximately 15 C&Q Engineers to deliver scope for facilities, utilities, and process equipment

Oversee the development and execution of C&Q documentation in compliance with internal quality standards, cGMP requirements, and client procedures

Ensure team safety and compliance with site safety protocols

Coordinate and schedule project activities, mentor team members, and review deliverables

Collaborate with stakeholders to ensure an effective, efficient, and compliant C&Q program

Participate in system and equipment design reviews to ensure GMP compliance

Align C&Q strategy with business and project stakeholders and foster strong cross-functional relationships (Construction, Automation, Technical Operations)

Contribute to automation strategy and software design

Implement digital C&Q processes using KNEAT software for documentation and workflows

Manage change control activities in accordance with site procedures

Identify and implement best practices to enhance business and technical processes

Qualification

C&Q strategy developmentGMP complianceTeam managementRisk managementKNEAT softwareChange control managementCross-functional collaborationMentoring

Required