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Commissioning, Qualification, and Validation Project ...

Jacobs - Cary, NC

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Job Description

At Jacobs, we harness our expertise and passion for making a difference, looking forward with optimism. We don't just meet expectations; we strive to exceed them. As a Commissioning, Qualification, and Validation (CQV) Project Manager, you'll join a dynamic team dedicated to providing top-tier CQV project management for clients involved in the GMP product manufacturing sector. This role is client-facing, focusing on ensuring that CQV project deliverables meet standards in schedule, cost, scope, quality, and safety. We seek a motivated CQV Project Manager who values collaboration and is eager to challenge the norm. In this position, you will be responsible for: Developing CQV planning documents to effectively manage projects. Leading the execution of CQV protocols in alignment with Good Documentation Practices (GDPs). Investigating and resolving protocol exceptions or discrepancies. Overseeing the creation of technical and CQV summary reports. Managing the safe and effective startup of equipment. Conducting risk assessments and impact assessments. Establishing handover procedures from construction to the CQV team and then to the client. Setting metrics to measure key project success criteria and ensuring that deliverables align with project requirements. Building and maintaining client relationships as Jacobs' primary contact on project/client sites. Identifying and pursuing new project opportunities for Jacobs. Bring your curiosity, collaborative spirit, and exceptional organizational skills, and we'll support your growth and fulfillment as we work together to make a significant impact on the world. Qualifications: Bachelor's degree in Mechanical, Chemical, or Electrical Engineering, or an equivalent combination of experience and education. At least 10 years of CQV experience in the Life Sciences industry. Strong knowledge of CQV deliverables, team building, and client relationship management. Proven leadership experience, with a knack for monitoring progress against schedules and cost estimates, as well as training and mentoring junior staff. Willingness and flexibility to travel and work at various client locations. Ideal candidates will also possess: Experience in proposal development. Understanding of US FDA regulations (21 CFR 210, 211, 810) and EU EMEA regulations. Familiarity with industry guidance including: ISPE Baseline Guide 5 for Commissioning and Qualification ISPE GAMP V, A Risk-Based Approach to Compliant GMP Computerized Systems ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment ISPE Guidelines for Science and Risk-based Approach for Facilities, Systems, and Equipment ISPE Good Practice Guide for Applied Risk Management in CQV Six Sigma Certification. Join us in shaping the future of life sciences and construction. We can’t wait to see the impact we can make together! Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, medical condition, marital or domestic partner status, sexual orientation, gender identity, gender expression, disability, genetic information, military or veteran status, citizenship, or any other characteristic protected by applicable law.

Created: 2026-03-17

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