• Senior CQV Engineer Lead : Life Sciences

    Jacobs (Cary, NC)


    Here at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We don’t settle until we give our best and know that we’re making a difference.

     

    As a Senior Commissioning, Qualification, and Validation (CQV) Engineer/Lead, you’ll 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.

     

    You’ll be accountable for developing CQV planning documents to manage CQV projects, leading a team in 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. You’ll 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-tasking and collaboration, and extreme organizational skills and we’ll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together.

     

    • Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering or equivalent years of experience in lieu of degree

    • At least 8 years of CQV experience in the Life Sciences industry

    • Experience with at least one of the following:

    o Greenfield site start up

    o Bioreactors

    o CIP systems

    o SIP systems

    o Filtration/Purification

    • Understanding of Good Manufacturing Practices (GMPs)

    • Strong technical writing skills

    • Proficient with Microsoft Office - Word, Excel, PowerPoint, Project

    • Flexibility and willingness to travel and work at various clients’ locations

    Ideally, you’ll also have:

    • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations

    • Knowledge of industry guidance:

    o ISPE Baseline Guide 5 Commissioning and Qualification

    o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems

    o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

    o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011

    o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011

    • Six Sigma Certification

     

    #LifeSciences, #Bio/Pharma, #EPCMV, #globallifescience

    #LI-SH1

    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 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.