Process Engineer 1

Company Information

You Matter to Cambrex.

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 more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.


Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more!


Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!


Job Overview

Process Engineer 1 role is responsible for providing engineering support to API manufacturing operations, ensuring processes are executed safely, efficiently, and in compliance with cGMP requirements. The position supports process performance, technology transfers, investigations, and operational excellence initiatives to meet client and business objectives.


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/Skills

• Ability to integrate information from diverse areas/sources and independently develop creative solutions
• Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills
• Demonstrated ability to work in a diverse team environment
• Proficiency with Microsoft software (Word, Excel, PowerPoint)
• Exposure to broader analytical techniques (i.e., beyond USP compendial testing). Some supervisory experience
• Experience / proficiency with various information and documentation software (SAP, TrackWise, etc.)
• Leads with Integrity and Respect; Delivers Results; Demonstrates Business Acumen; Fosters Collaboration and Teamwork; Champions Change; Engages and Inspires; Coaches and Develops

Education, Experience & Licensing Requirements
• BS in Chemical Engineering, plus 1 - 3 years of experience in 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
• Proficient in Windows-based environment including word processing, spreadsheet, and data base programs

#CB

#LI-RD1
• A Chemical Manufacturing environment.
• Involves periodic use of basic PPE (personal protective equipment) such as supplied air respirator, negative pressure respirator, gloves, safety glasses, shielding clothing.