Process Engineer III
3 weeks ago
Croda is seeking a highly skilled Process Engineer III to join our team. As a Process Engineer III, you will be responsible for performing and/or leading a wide array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment.
Key Responsibilities:- Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing manufacturing processes
- Assist in the design and procurement of new equipment and lead commissioning, start-up, installation, or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports
- Assess equipment changes (repairs, replacement, automation, improvements, etc.) for impact to validated processes and, if necessary, perform process qualification or re-validation
- Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements
- Work on multiple process development and validation projects simultaneously and coordinate test work with various other departments
- Write procedures, protocols, and technical reports for manufacturing, utility, performance qualifications, lab equipment, cleaning, and process validation
- Compile validation packages and assure all required documentation is accurate and complete
- Champion process improvement projects and ensure equipment and systems remain in a qualified state
- Lead or assist in general investigations (from deviations, OOS Investigation, Batch Failures, customer complaints, etc.)
- Lead or assist in equipment/process related risk assessment exercises for potential changes to equipment/processes
- Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
- Point person for process improvement activities; including performing or authoring equipment specifications, develop, or assist with development by subject matter experts, user, and functional requirements specifications for new equipment, and necessary FAT and SAT protocols (as required)
- Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances, and intervals, drawing updates, and support of out-of-tolerance investigations related to instrument calibrations
- BS degree in Chemical Engineering or related life science
- Minimum of 10 plus years of previous relevant work experience in a related field required
- Experience providing technical support in a cGMP manufacturing environment including hands-on process development, optimization, and troubleshooting of equipment and processes is preferred
- Experience with any of the following: process equipment, filling or packaging equipment, cleaning validation planning and execution, piping and instrumentation diagrams (P&ID), chemical process engineering, and pharmaceutical process development is preferred
Croda is a global leader in specialty chemicals. We are passionate about developing and utilizing new technologies to shape and inspire changes within an ever-growing marketplace. We are committed to diversity and inclusion and are an equal opportunity employer.
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