Jacobs McPherson, Kansas, United States
Dec 31, 2018Full time
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. Job Description The Commissioning, Qualification and Validation (CQV) Engineer will provide CQV services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This position shall be responsible for the development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers. Technical/Functional Responsibilities: Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices: Develop and execute CQV protocols for a Bosch Filler and its associated equipment. Develop CQV planning documents to manage CQV projects Develop and execute CQV protocols using Good Documentation Practices (GDPs) Investigate and resolve protocol exceptions or discrepancies Develop technical reports and CQV summary reports Startup equipment in a safe and effective manner Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.) Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation Perform risk assessments and impact assessments Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients Qualifications Minimum Qualifications: The ideal candidate for this position will possess the following: Bosch Filling Line Experience BS in Mechanical, Chemical or Electrical Engineering or equivalent 5-14 years of CQV experience in the life sciences industry Understanding of Good Manufacturing Practices (GMPs) Technical writing skills Proficient with Microsoft Office – Word, Excel, PowerPoint, Project Flexibility and willingness to travel and work at various clients’ locations Ability to work well with diverse, multi-disciplined groups Ability to effectively communicate with management and fellow project team members Ability to negotiate/compromise with other project team members to achieve project goals Ability to listen and respect fellow project team member’s ideas and opinions and work through conflicts or disagreements Preferred Qualifications: Aseptic processing experience Cleaning validation experience Process validation experience 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 Candidates must have unrestricted rights to work in the U.S. 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.