Job Description:
Cambrex
Process Engineer I
US-IA-Charles City
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
PI249986555
Salary:
$79,618.00More jobs in Charles City, Iowa
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