Manufacturing Technician (Drug Substance Manufacturing)

Cambrex•Longmont, CO

2d•Onsite

About The Position

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.

Requirements

Basic understanding of cGMP and GDP requirements for drug substance manufacturing operations.
Able to apply learned knowledge of equipment and facility maintenance for the GMP and non-GMP production areas.
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 perform other duties as assigned without hindering obligations.

Nice To Haves

Good mechanical aptitude preferred.

Responsibilities

Properly sets up, operates, breaks down and cleans production equipment per written procedures.
Maintains cGMP suites to be tour/audit ready and prepared for manufacturing activities.
Functions independently on basic to intermediate scale-up operations of drug substance in assigned manufacturing area.
Understands and follows written procedures.
Consistently, clearly, and accurately documents activities for production records and manufacturing equipment in accordance with ALCOA, GMP, and Good Documentation Practices (GDP).
Performs routine equipment maintenance/preventative maintenance activities. Basic mechanical aptitude and able 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.
Works with or around hazardous waste. It is expected that you will receive and maintain Resource Conservation and Recovery Act (RCRA) training annually.
Identifies and stocks equipment/parts as needed for manufacturing processes.