Manufacturing Technician; Drug Substance Manufacturing

Overview

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 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.

• 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. 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 perform other duties as assigned without hindering obligations.

• High school diploma or equivalent with 6 months of experience in a regulated environment preferred, or a BS in a technical field with relevant experience.
• This position may be filled as Manufacturing Technician I, II, or III depending on education, experience, skills, and abilities.

Compensation: The hiring range in Colorado for this position is $31.80/hour - $35.65/hour and is eligible for a 4% annual target bonus. Actual base pay within this range will vary depending on job-related knowledge, education, skills and experience of the applicant. This information is provided pursuant to Colorado's Ensure Equal Pay for Equal Work Act.

Benefits: Benefits include medical, prescription, dental, and vision coverage; HSA and FSA options; a 401(k)-retirement savings plan with employer match; paid time off; paid sick leave; employer‑paid life and disability coverage; paid parental leave after one year of service; and wellness and emotional support programs.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including…