Title: Project Engineer
Applies engineering principles to design, modify, or develop facilities, testing, machines, equipment, or processes used in the processing, testing, manufacturing, and packaging of pharmaceutical products by performing the following duties.
- Analyzes product or equipment specifications and performance requirements to determine designs that can be produced by existing manufacturing or processing facilities and methods.
- Analyzes engineering proposals, process requirements, and related technical data pertaining to facilities and equipment.
- Manage all aspects of capital projects, as required, from conception to completion, including budgets, documentation, scheduling, and contractors.
- Author, manage, and execute all aspects of required Qualification and Computer Validation Documentation as it relates to facility, equipment and/or computer systems.
- Determines feasibility of designing new plant equipment or modifying existing facilities considering costs, available space, time limitations, company planning, and other technical and economic factors.
- Provides technical information concerning manufacturing or processing techniques, materials, properties, and process advantages and limitations which affect long range plant and product engineering planning.
- Compiles and analyzes operational, test, and research data to establish performance standards for newly designed or modified equipment.
- Studies engineering and technical publications to keep abreast of technical changes and developments in industry.
- Uses computer assisted engineering and design software and equipment to perform engineering tasks.
- Provides technical expertise and assistance to the Facilities & Engineering Department for troubleshooting and investigating equipment, facility, and cGMP related issues, including updating documentation, instituting procedures, and authoring/executing qualifications.
- Perform other duties as assigned.
- Bachelor’s degree (B. S.) in Engineering (Mechanical preferred).
- Three plus years related experience in an industrial manufacturing environment.
- Prior pharmaceutical industry experience is a preferred.
Knowledge and Skills
- Good written and oral communication skills.
- To perform this job successfully, an individual should have knowledge of Design software; Project Management software; Spreadsheet software and Word Processing software. Proficient in Auto Cad.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.