Job ID: 2024-3922 Type: Regular Full-Time # of Openings: 1 Category: Operations Cambrex - Charles City
Overview
The Process Engineer will be responsible for implementation of projects for the manufacture of APIs and bulk intermediates and other products from development through piloting and/or commercial production.
Responsibilities
Writing batch records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports with minimal oversight to support production operations
Identifying and monitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality or customer expectations
Identifying and executing Kaizen events with support from Process Improvement
Providing training and process support to production areas including training on new processes and on-site oversight of key processing steps
Working in a team environment that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development and Operations
Developing plans for production of pilot and commercial volumes of product
Developing and maintaining IQ, OQ and PQ documents and protocols with minimal oversight
Leading efforts to troubleshoot and investigate process problems and deviations with minimal guidance, and preparing appropriate reports on findings
Participating in HAZOPs and providing guidance on corrective actions when needed
Providing PFD and P&ID generation, energy balances, material balances, environmental calculations and other calculations and formulations as needed
Working with appropriate departments to set up codes, label requests, and MSDS revisions
Completing CAPAs and audit action items as assigned
Qualifications
BS in Chemical Engineering, plus 1 - 5years or more of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience
