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Jacobs Senior CQV Engineer (Life Sciences) in Indianapolis, Indiana

Your Impact:

Our People & Places Solutions business – reinforces our drive to improve the lives of people everywhere and epitomizes the "why" of what we do – the tremendous positive impact and value our solutions bring to our communities and society as a whole. From facilities delivering life-saving therapies and ensuring clean water to enabling the connection of people through all modes of transportation and providing access to technology – we're integrating a multitude of these solution elements to build the smart environments of tomorrow.

Start your Jacobs career with a company that inspires and empowers you to deliver your best work so you can evolve, grow and succeed – today and into tomorrow.

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, 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, 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. 

Here’s what you’ll need :

  • 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

  • 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

  • Client facing experience

  • Experience in interface with Design and CM

  • Strong experience with system boundary definitions, system impact assessments, risk assessments

  • Strong experience with qualification of process equipment and utilities

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, #CQV

At Jacobs, we’re challenging today to reinvent tomorrow by solving the world’s most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discovery and cutting-edge manufacturing, turning abstract ideas into realities that transform the world for good. With $15 billion in revenue and a talent force of more than 60,000, Jacobs provides a full spectrum of professional services including consulting, technical, scientific and project delivery for the government and private sector.

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.