Senior Project Manager, CQV

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          "text": "<p>CRB is looking for an energetic, self-motivated individual for the role of&#xa0;Sr. Manager&#xa0;of&#xa0;Commissioning, Qualification and Validation&#xa0;(CQV).&#xa0;The&#xa0;Sr. Manager&#xa0;will&#xa0;support the integration and delivery of CQV services for our Life Sciences clients. Their focus will be to provide guidance on daily operations of the CQV team, including internal and external CQV resources, for all regional projects from proposal stage to facility turnover – this will include leading resources through regulatory requirements, devising and executing strategies, and meeting timelines with risk mitigation. This position requires&#xa0;a high level&#xa0;of organization, communication, leadership, and interpersonal skills that will be used to build strong relationships with internal and external clients. They will&#xa0;represent&#xa0;CRB in a professional manner,&#xa0;assist&#xa0;in winning work, and understand how their strategy directly&#xa0;impacts&#xa0;our collective success.&#xa0;</p><ul><li><p>The&#xa0;Sr. Manager&#xa0;of CQV&#xa0;will provide guidance &amp; support&#xa0;for&#xa0;daily operations of the CQV team, including internal and external CQV resources, for all regional projects from proposal stage to facility turnover&#xa0;</p></li></ul><ul><li><p>Manage and perform the development of validation protocols, the development of validation studies, data analysis, and compilation of the data and results into final reports&#xa0;</p></li></ul><ul><li><p>Review &amp; Approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA).&#xa0;</p></li></ul><ul><li><p>As a subject matter expert, represent these activities in discussions and communications with Clients and regulatory agencies&#xa0;</p></li></ul><ul><li><p>Collaborate in the development of specific CQV plans and ensuring integration with design and construction plans&#xa0;</p></li></ul><ul><li><p>Responsible for the implementation and execution of the periodic system reviews and requalification activities, as needed&#xa0;</p></li></ul><ul><li><p>Develop execution schedule and planning efforts on all&#xa0;ONEsolution&#xa0;projects&#xa0;</p></li></ul><ul><li><p>Interact with regulatory authorities during audits&#xa0;</p></li></ul><ul><li><p>Mentoring &amp; training employees, both internal and external, on the CQV approach as it relates to each project&#xa0;&#xa0;</p></li></ul><ul><li><p>Supporting the development of internal qualification documents&#xa0;</p></li></ul><ul><li><p>Assess impact&#xa0;to&#xa0;validated&#xa0;status of new systems and changes to existing systems using a quality risk-based approach.&#xa0;</p></li></ul><p>&#xa0;</p>",
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          "text": "<p>CRB's over 1,200 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our&#xa0;<a href=\"https://www.crbgroup.com/about-crb\" rel=\"noopener noreferrer\">mission, vision, and core values</a>&#xa0;put client satisfaction and employee experience at the center of everything we do.</p><p>As an AEC Firm we proudly specialize in industries that inherently carry important social responsibility - we recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.</p>",
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