Process Engineer I

<br /><b>Cambrex</b><br /><br /><br /><b>Process Engineer I</b><br /><br />US-IA-Charles City<br /><br /><b>Job ID:</b> 2024-3759<br /><b>Type:</b> Regular Full-Time<br /><b># of Openings:</b> 1<br /><b>Category:</b> Operations<br />Cambrex - Charles City<br /><br /><b>Overview</b><br /><br /><p><span><span><span>The P</span><span>rocess Engineer </span><span>I </span><span>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.</span></span><span> </span></span></p><br /><br /><b>Responsibilities</b><br /><br /><ul><li><span><span>Writing</span><span> batch records, cleaning records, </span><span>SOPs, </span><span>campaign reports, supplements, and investigation</span><span>/deviation</span><span> reports as needed to support production operations</span></span><span> </span></li><li><span><span>Monitoring KPIs and using process data to </span><span>identify</span><span> and execute </span><span>improvements to </span><span>new and </span><span>existing products to achieve improved yields, </span><span>quality</span><span> or customer expectations</span></span><span> </span></li><li><span><span>Working with process improvement to </span><span>identify</span><span> and execute Kaizen events</span></span><span> </span></li><li><span><span>Providing </span><span>training and </span><span>process support to production areas including </span><span>training on new processes and </span><span>on-site oversight of key processing steps</span></span><span> </span></li><li><span><span>Working in a team environment that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development and Operations</span></span><span> </span></li><li><span><span>Developing plans for production of pilot and commercial volumes of product</span></span><span> </span></li><li><span><span>Developing and </span><span>maintaining</span><span> IQ, OQ and PQ documents and protocols</span></span><span> </span></li><li><span><span>Troubleshooting, investigating process problems and deviations, and preparing </span><span>appropriate reports</span><span> on findings</span></span><span> </span></li><li><span><span>Participating in HAZOPs and providing guidance on corrective actions when needed</span></span><span> </span></li><li><span><span>Providing PFD and P&ID generation, energy balances, material balances, environmental calculations and other calculations and formulations as needed</span></span><span> </span></li><li><span><span>Working with </span><span>appropriate departments</span><span> to set up codes, label requests, and MSDS revisions</span></span><span> </span></li><li><span><span>Completing CAPAs and audit action items as assigned</span></span><span> </span></li></ul><p><span> </span></p><p><span><span>All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.</span></span><span> </span></p><br /><br /><b>Qualifications</b><br /><br /><p><span><span><span>BS</span><span> in Chemical Engineering, plus 1 – 3 </span><span>years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience</span></span><span> </span></span></p><p> </p><br /><br /><br /><img src="https://www.click2apply.net/v/rJzDpKH7EPd5qcZwVIrWZM" /><br /><br /><p>PI241964903</p>