Senior Project Manager, CQV at CRB in Raleigh, NC

companyDescription 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 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. jobDescription 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 of validation studies, data analysis, and compilation of the data and results into final reports Review & Approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA). As a subject matter expert, represent these activities in discussions and communications with Clients and regulatory agencies Collaborate in the development of specific CQV plans and ensuring integration with design and construction plans Responsible for the implementation and execution of the periodic system reviews and requalification activities, as needed Develop execution schedule and planning efforts on all ONEsolution projects Interact with regulatory authorities during audits Mentoring & training employees, both internal and external, on the CQV approach as it relates to each project Supporting the development of internal qualification documents Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach. qualifications Bachelor’s Degree in Architecture, Engineering, or Construction Management, or similar degree preferred, or equivalent years of relevant industry experience. 9+ years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences and/or regulated Industry; Sound technical knowledge of both US and global regulatory requirements. Proficient in cGMP and SUPAC standards. Demonstrated effective leadership and collaboration skills Direct experience in managing Commissioning, Qualification and Validation deliverables Excellent organizational, interpersonal, presentation, and communication skills Commitment to technical excellence, as well as creating world-class experiences for our clients and employees Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations, ISPE Baseline Guide 5 Commissioning and Qualification and ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011 Experience using statistical, risk assessment, and process improvement tools. Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator Ability to plan and execute Smoke / Airflow Visualization Studies Interpersonal and leadership skills necessary to communicate clearly, and effectively manage qualification/validation activities with all levels of personnel from various disciplines across the organization. Flexible and willing to travel as needed additionalInformation All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.