This role is located in San Antonio. Direct hire Client will pay relo/interview expenses.
The Process Engineer is responsible for the evaluation of new or existing products by providing process (Compounding & Packaging) and equipment evaluations for feasibility, resource and cost estimating, documentation generation & review, execution of projects and engineering studies, and overall customer support as required.
1. Generate Request For Estimates (RFE’s) for Packaging and Compounding based on a specific product characteristics including all required equipment estimates.. 2. Provides recomendations for production equipment to Manufacturing. 3. Provides support to Project Engineering to coordinate and select process equipment 4. Provides support to Project Management and Commercial Operations with impact evaluation of product changes/modifications. 5. Writes and develops Operational SOP’s for startup and equipment operation. 6. Develops and executes change parts evaluations for new products and/or component changes. 7. Responsible for implementation of facility and production related project including all facets of Project Development, Project Execution and Project Closeout 8. Review and approve Packaging modules; develop first draft of Packaging Set-Up Modules 9. Support R&D Packaging Engineers in new product & process development and evaluation & coordination of Engineering Studies. 10. Provide support to QTS/Validation in documentation generation and execution; support Quality in investigations and corrective actions. Note:Within my areas of responsibility, understand and comply with all DFB Pharmaceuticals, Inc. safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
Education: Bachelor’s degree Bachelor’s degree (B.A.) in Engineering from four-year College or University.
Experience: 3 – 5 years Pharmaceutical Manufacturing (cGMP)
Language: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Math: Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems.
Reasoning: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.