CRB
Life Sciences
SeniorProjectManager,CQV
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“Senior Project Manager, CQV at CRB. Skills: Commissioning, Qualification, Validation, Compliance. Provide guidance on daily operations. Support daily operations of CQV team”
What You'll Achieve.
Meet timelines; Mitigate risk
Industry & Context.
Risk assessment; Quality risk-based approach
Willing to travel
What They're Looking For.
Must Have
9+ years CQV experience, Sound technical knowledge of regulatory requirements, Proficient in cGMP and SUPAC standards, Demonstrated leadership and collaboration skills, Direct experience managing CQV deliverables, Excellent organizational skills, Excellent interpersonal skills, Excellent presentation skills, Excellent communication skills, Commitment to technical excellence, Experience using statistical tools, Experience using risk assessment tools, Experience using process improvement tools, Ability to plan Smoke Visualization Studies, Ability to execute Smoke Visualization Studies, Ability to plan Airflow Visualization Studies, Ability to execute Airflow Visualization Studies, Interpersonal skills to communicate clearly, Leadership skills to communicate clearly, Manage qualification activities with all levels, Manage validation activities with all levels
Nice to Have
Bachelor's Degree in Architecture, Bachelor's Degree in Engineering, Bachelor's Degree in Construction Management, Bachelor's Degree in similar field, Equivalent years of industry experience
What You'll Do.
Provide guidance on daily operations
Support daily operations of CQV team
Manage development of validation protocols
Perform development of validation protocols
Manage development of validation studies
Perform development of validation studies
Perform data analysis
Compile data and results into reports
Review User Requirements Specifications
Approve User Requirements Specifications
Review Functional Specifications
Approve Functional Specifications
Review Design Specifications
Approve Design Specifications
Review Change controls
Approve Change controls
Review equipment Failure Mode and Effects Analysis
Approve equipment Failure Mode and Effects Analysis
Review process Failure Mode and Effects Analysis
Approve process Failure Mode and Effects Analysis
Represent activities in discussions with Clients
Represent activities in communications with Clients
Represent activities in discussions with regulatory agencies
Represent activities in communications with regulatory agencies
Collaborate in CQV plan development
Ensure integration with design plans
Ensure integration with construction plans
Execute periodic system reviews
Execute requalification activities
Develop execution schedule
Develop planning efforts
Interact with regulatory authorities during audits
Mentor employees on CQV approach
Train employees on CQV approach
Support development of internal qualification documents
Assess impact to validated status
Assess changes to existing systems
How You'll Work.
Team & Collaboration
Internal CQV resources; External CQV resources; Cross-functional teams
Communication Scope
Client communication; Regulatory communication; Interpersonal communication
Process & Methodology
Risk mitigation, Scheduling, Planning
Full Job Description
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 [mission, vision, and core values](https://www.crbgroup.com/about-crb) put client satisfaction and employee experience at the center of everything we do. 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. CRB is looking for an energetic, self-motivated individual for the role of Sr. Manager of Commissioning, Qualification and Validation (CQV). The Sr. Manager will 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 a high level of organization, communication, leadership, and interpersonal skills that will be used to build strong relationships with internal and external clients. They will represent CRB in a professional manner, assist in winning work, and understand how their strategy directly impacts our collective success. * The Sr. Manager of CQV will provide guidance & support for daily operations of the CQV team, including internal and external CQV resources, for all regional projects from proposal stage to facility turnover * Manage and perform the development of validation protocols, the development
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