Senior CQV Engineer; LSNA-IN​/VA

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.

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. You will be accountable for developing CQV planning documents, generating and executing CQV protocols using Good Documentation Practices (GDPs), investigating and resolving protocol exceptions or discrepancies, developing technical reports and CQV summary reports, and startup of equipment in a safe and effective manner;

as well as performing risk assessments and impact assessments. You’ll also be responsible for reading and verifying facility and equipment drawings (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.

• 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 or advanced manufacturing 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

• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
• Knowledge of industry guidance
• ISPE Baseline Guide 5 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 Guideline Science and Risk‑based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
• ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011
• Six Sigma Certification

This position will be onsite at either our Lebanon, Indiana or Richmond, Virginia site locations.

Our health and welfare benefits are designed to invest in you, and in the things you care about. Your health. Your well‑being. Your security. Your future. Employees have access to medical, dental, vision, and basic life insurance, a 401(k) plan, and the ability to purchase company stock at a discount. Eligible employees may also enroll in a deferred compensation plan or the Executive Deferral Plan.

Jacobs has an unlimited U.S. Personalized Paid Time Off (PPTO) policy for full‑time salaried/exempt employees, seven paid holidays, and caregiver leave. And certain roles may be eligible for additional rewards, including merit increases, performance discretionary bonus, and stock.

The base salary range for this position is $ to $. Within the range, individual pay is determined by work location and additional factors, including job‑related skills, experience, and relevant education or training.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Onsite employees are expected to attend a Jacobs Workplace on a full‑time basis, as required by the nature of their role.