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Senior CQV Engineer (LSNA)

Jacobs - Indianapolis, IN

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Job Description

Here at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We donu2019t settle until we give our best and know that weu2019re making a difference.As a Senior Commissioning, Qualification, and Validation (CQV) Engineer, youu2019ll join our collaborative team providing CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. We are looking for a passionate Senior CQV Engineer who is driven by collaboration, exceeding expectations, and challenging the status quo.Youu2019ll be accountable for developing CQV planning documents to manage CQV projects, generating and executing CQV protocols using Good Documentation Practices (GDPs), investigating and resolving protocols exceptions or discrepancies, developing technical reports and CQV summary reports, and starting up equipment in a safe and effective manner; as well as performing risk assessments and impact assessments. Youu2019ll also be accountable for reading and verifying facility and equipment drawing (e.g., P&IDs, AF&IDs, etc.), developing Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.Bring your curiosity, talent for multi-taskingand collaboration, and extreme organizational skills and weu2019ll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together. u2022 Bacheloru2019s degree in Mechanical, Chemical, or Electrical Engineering or equivalent years of experience in lieu of degreeu2022 At least 8 years of CQV experience in the Life Sciences industryu2022 Understanding of Good Manufacturing Practices (GMPs)u2022 Strong technical writing skillsu2022 Proficient with Microsoft Office - Word, Excel, PowerPoint, Projectu2022 Flexibility and willingness to travel and work at various clientsu2019 locationsIdeally, youu2019ll also have:u2022 Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulationsu2022 Knowledge of industry guidance:o ISPE Baseline Guide 5 Commissioning and Qualificationo ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systemso ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipmento ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011u2022 Six Sigma Certification#LifeSciences, #Bio/Pharma, #EPCMV, #globallifescience#LI-SH1Jacobs 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 medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. Learn more about your rights under Federal EEO laws and supplemental language.

Created: 2026-02-12

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