Manufacturing Technician; Drug Substance Manufacturing

Overview

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 healthcare, life insurance, planning for retirement, 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!

The Manufacturing Technician will maintain GMP suites for manufacturing activities by properly setting up, breaking down, operating, and cleaning production equipment for both GMP and non-GMP drug substance manufacturing operations. The applicant should have relevant experience with manufacturing processing equipment, material handling, and GMP operations in drug substance or drug product manufacturing.

• Properly set up, operate, break down and clean production equipment per written procedures.
• Maintain cGMP suites to be tour/audit ready and prepared for manufacturing activities.
• Function independently on basic to intermediate scale-up operations of drug substance in assigned manufacturing area.
• Understand and follow written procedures.
• Consistently, clearly, and accurately document activities for production records and manufacturing equipment in accordance with ALCOA, GMP, and GDP.
• Perform routine equipment maintenance/preventative maintenance activities. Basic mechanical aptitude and ability to repair production equipment with guidance as needed.
• Clean production suites, hoods, and equipment in accordance with standard operating procedures using good chemical hygiene practices.
• Work with or around hazardous waste. Annual Resource Conservation and Recovery Act (RCRA) training is required.
• Identify and stock equipment/parts as needed for manufacturing processes.

• Basic understanding of cGMP and GDP requirements for drug substance manufacturing operations.
• Able to apply learned knowledge of equipment and facility maintenance for GMP and non-GMP production areas. Good mechanical aptitude preferred.
• Basic to intermediate knowledge of manufacturing equipment operations including batch reactors, filters, dryers, and pumps, as well as handling glass lab equipment.
• Basic chemical processing skills, including weighing, calculations, GMP documentation, vacuum, pressure, and filtration techniques.
• Ability to wear respirators and various types of PPE while promoting a safe work environment.
• Able to read and comprehend detailed written instructions. Provides feedback to ensure instructions are accurate and can be performed as written.
• Must adhere to the Cambrex attendance policy. Employee should be punctual, reliable, and willing to work outside of normal working hours as requested.
• Effectively communicates both verbally and in writing.
• Able to perform basic to intermediate mathematical calculations including inventory reconciliation.
• Able to work independently or within a team environment with minimal supervision.
• Shows initiative, high attention to detail and performs tasks with minimal supervision.
• Able to troubleshoot and communicates potential roadblocks to management.
• Flexibility and time management skills to…