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Lead Process Engineer
- Jacobs (Indianapolis, IN)
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Lead the design of pharmaceutical processes ensuring compliance with all applicable codes and regulations, including active pharmaceutical ingredients, biologics, aseptic processing, high potency compounds’ containment, formulation, filling, lyophilization, inspection, packaging unit operations, and clean utilities. Develop block flow diagrams, process flow diagrams, material and energy balances, Pipe & instrumentation Diagrams, data sheets for equipment, instruments, and safety devices, cause-effect matrices, and other common process activities. Specify critical components, ensuring that the design meets all regulatory requirements, and continuously review and analyze new equipment, applications, and technology for compliance. Prepare and assess technical aspects of each bid and purchase specifications for process equipment packages to ensure they meet the specified requirements. This includes checking compliance with technical specifications, performance criteria, and quality standards. Identify the specific clean utilities needed (e.g., purified water, clean steam, compressed air) and their usage rates and peak demand for each utility based on the maximum usage scenarios. Calculate the pressure drop across the pipeline to ensure it is within acceptable limits and ensure the fluid velocity is within recommended ranges to avoid issues like erosion or water hammer, as well as, account for friction losses due to pipe roughness and fittings. Select appropriate valves, fittings, and other components to ensure reliable operation and implement control systems to monitor and regulate the distribution of utilities. Engage with relevant stakeholders, including engineers, operators, and maintenance personnel, to gather input on the equipment requirements. This includes technical specifications, performance criteria, and any regulatory standards that must be met. Interface with detailed disciplines and provide support for design coordination activities, ensuring all regulatory requirements are addressed. Identify potential risks associated with the design, procurement and installation to develop strategies to mitigate them.
Hybrid schedule is allowed.
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REQUIREMENTS: This position requires a bachelor's degree or foreign equivalent in Chemical Engineering or related field and 10 years of work experience in the job offered or related occupation.
Travel: 10% domestic travel to client sites.
SPECIFIC SKILLS:
Expertise and knowledge of: Active Pharmaceutical Ingredients (API) Technologies. Fill Finish Technologies - Aseptic Processing, Formulation, Filling, Lyophilization, and Inspection Packaging Unit Operations. High potency compounds and containment strategy. Design of Clean Utilities, Generation and Distribution Systems. Development of Block Flow Diagrams, Process Flow Diagrams, Piping and Instrument Diagrams along with associated Material and Energy Balances. Preparation and evaluation of the technical aspects of bid and purchase specifications for process equipment packages relating to the technologies listed above. Calculating loads for utilities, line sizing, pump hydraulics and distribution design. Planning, cost development, and scheduling for assigned projects. Interfacing with other engineering disciplines to calculate and provide instrument process data, electrical loadings, layout requirements etc. GMP and worldwide regulatory requirements. PipeFlo (Professional and Compressible). AFT Products (Arrow and Fathom). Aspen Hysys and Aspen Plus. Schedule Pro. Bluebeam.
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.
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