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: Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Overview:

The Process Engineer I 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 – 3 years or more of experience in manufacturing environment, preferably in pharmaceutical manufacturing; 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
• Proficient in windows based environment including word processing, spreadsheet and data base programs