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Senior Manager of Commissioning, Qualification, and Validation

On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

A Bachelor’s Degree in Architecture, Engineering, Construction Management, or a related field is preferred, or equivalent years of relevant experience. More than 9 years of experience in Commissioning, Qualification, Validation, and Compliance within the Life Sciences and/or regulated industries, with a robust understanding of both U. S. and global regulatory standards. Proficiency in cGMP and SUPAC standards is essential. Proven leadership and collaboration capabilities. Direct experience in managing Commissioning, Qualification, and Validation deliverables. Outstanding organizational, interpersonal, presentation, and communication skills. A commitment to technical excellence and delivering world-class experiences for clients and team members. Familiarity with U. S. FDA regulations (21 CFR 210, 211, 810) and EU EMEA regulations.

About the job

Join CRB as a Senior Manager of Commissioning, Qualification, and Validation (CQV) and be a key player in delivering exceptional CQV services to our esteemed Life Sciences clients. This dynamic role requires a proactive and self-driven individual to oversee the daily operations of the CQV team, ensuring effective collaboration with both internal and external resources across various regional projects from the proposal phase through to facility turnover. Your responsibilities will encompass guiding teams through regulatory compliance, formulating and implementing strategies, and managing timelines while mitigating risks.

In this leadership position, you will utilize your exceptional organizational, communication, and interpersonal skills to forge strong relationships with clients and stakeholders. You will represent CRB with professionalism and contribute directly to our success by assisting in securing new projects.

  • Lead the CQV team’s daily operations, including resource management across regional projects.

  • Oversee the creation and execution of validation protocols, studies, and comprehensive final reports.

  • Review and approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and process Failure Mode and Effects Analysis (FMEA).

  • Act as a subject matter expert in discussions with clients and regulatory bodies.

  • Collaborate on the development of tailored CQV plans that integrate with design and construction initiatives.

  • Implement and manage periodic system reviews and requalification activities.

  • Develop execution schedules for all ONEsolution projects.

  • Engage with regulatory authorities during audits.

  • Mentor and train both internal and external employees on CQV methodologies pertinent to each project.

  • Support the formulation of internal qualification documentation.

  • Evaluate the impact of new systems and changes on validated statuses using a quality risk-based approach.

About CRB Group Inc.

At CRB, our team of over 1,200 skilled professionals is dedicated to creating innovative, life-changing, and life-saving solutions for manufacturers in the life sciences and food and beverage sectors. Our mission, vision, and core values place a strong emphasis on client satisfaction and enhancing the employee experience. As an AEC firm, we take pride in specializing in industries with significant social responsibility. We acknowledge the influence we have in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. Our projects, from oncology and rare disorders to addressing food scarcity and global health challenges, are pioneering solutions that matter.

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