Jacobs CQV Engineer - 2 in Indianapolis, Indiana
CQV Engineer - 2
Jacobs serves the PharmaBio, Chemicals, Refining, Pulp & Paper, Power & Utilities, High Tech and Consumer Products Industries. Our core life sciences network has contributed to becoming the largest provider of engineering and construction services to pharmaceutical and biotechnology clients and we have established ourselves as the center of excellence for Pulp and Paper facilities. Jacobs provides full-service engineering, procurement, and construction management services for both new and existing facilities, offering environmental and water / wastewater support, energy audits, and hygienic / sanitary assessments. For projects of every scale we provide design, engineering, construction, commissioning, and maintenance services that support a facility's entire life cycle.
The Commissioning,Qualification and Validation (CQV) Engineer will provide CQV services toclients in the Life Sciences Industry. The position provides an excellentopportunity to work for a Global Engineering Firm and support clients thatmanufacture life changing products. This position shall be responsible for the developmentand execution of CQV documentation on a variety of equipment, facilities,utilities, components, products, and systems for a diverse client base ofbiotechnology, pharmaceutical, medical device, gene therapy and cell therapymanufacturers.
ProvideCQV support to clients that manufacture GMP products on a consistent basis inconjunction with industry best practices:
Develop CQV planningdocuments to manage CQV projects
Generate and execute CQVprotocols using Good Documentation Practices (GDPs)
Investigate andresolve protocol exceptions or discrepancies
Develop technicalreports and CQV summary reports
Startup equipment ina safe and effective manner
Read and verify facilityand equipment drawings (e.g., P&IDs, AF&IDs, etc.)
Develop StandardOperating Procedures (SOPs), process workflows, Validation Master Plans, UserRequirement Specifications, Turnover Packages, and other regulatory supportdocumentation
Perform riskassessments and impact assessments
Apply engineeringknowledge of, and experience with, manufacturing equipment, process equipment,HVAC, utilities, instrumentation, controls, and automation to support clients
Theideal candidate for this position will possess the following:
BSin Mechanical, Chemical or Electrical Engineering or equivalent
0- 7 years of CQV experience in the life sciences industry
Understandingof Good Manufacturing Practices (GMPs)
Proficientwith Microsoft Office – Word, Excel, PowerPoint, Project
Flexibilityand willingness to travel and work at various clients’ locations
Abilityto work well with diverse, multi-disciplined groups
Abilityto effectively communicate with management and fellow project team members
Abilityto negotiate/compromise with other project team members to achieve projectgoals
Abilityto listen and respect fellow project team member’s ideas and opinions and workthrough conflicts or disagreements
Ability to use testand measurement equipment (e.g., KAYE Validators)
Knowledge of US FDA (21CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industryguidance:
ISPE Baseline Guide 5Commissioning and Qualification
ISPE GAMP V, A RiskBased Approach to Compliant GMP Computerized Systems
ASTM E2500 StandardGuide for Specification, Design, and Verification of Pharmaceutical andBiopharmaceutical Manufacturing Systems and Equipment
ISPEGuideline: Science and Risk-based Approach for the Delivery of Facilities,Systems, and Equipment, 2011
ISPEGood Practice Guide: Applied Risk Management for Commissioning andQualification, 2011
Candidates must haveunrestricted rights to work in the U.S.
At Jacobs, we help prepare people for newopportunities and challenges. With positions at every level, openings inmultiple disciplines, expertise in a range of markets and offices around theglobe, we create an environment where you can learn, grow, and thrive. From ourcompetitive benefits program to our Health and Safety initiative of Beyond Zeroworkplace injuries, we believe that you'll find a flourishing career here atJacobs.
Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Jacobs is a background screening, drug-free workplace.
Primary Location United States-Indiana-Indianapolis
Req ID: LIF00003J