Process Engineer 2 at Cambrex in High Point, North Carolina

Job Description:

Cambrex


Process Engineer 2

US-NC-High Point

Job ID: 2024-4004
Type: Regular Full-Time
# of Openings: 1
Category: Operations
Cambrex - High Point

Overview

The Process Engineer 2 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

• Composing batch production records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports as needed 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
• Working with Process Improvement resources where applicable to drive optimization of production
• Providing targeted training and process support to production areas, including training on new processes, as well as on-site oversight of key processing steps
• Working in a team environment that includes cross-departmental participation from Facilities, Chemical Research and Development, Regulatory, Quality Control, and Analytical Research and Development
• Developing plans and process fits for production
• Developing and maintaining IQ, OQ and PQ documents and protocols
• Leading and coordinating troubleshooting efforts where appropriate, investigating process problems and deviations, and preparing appropriate reports on findings
• Participating in HAZOPs and other S&IH reviews, and providing guidance on corrective actions when needed
• Where required, providing PFDs, energy balances, material balances, environmental calculations, and other pertinent production information
• 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 3 - 7 years of experience in a manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience
• Knowledge of and/or direct experience in a cGMP environment is preferred
• General knowledge of chemical operations equipment and manufacturing operations

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