Manufacturing Operator

Company Overview

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 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

The Manufacturing Operator will properly operate solid dose manufacturing equipment to produce drug products. Personnel will operate processing equipment by following standard operating procedures and batch records in accordance with FDA cGMPs. The main focus is to operate, set‑up, and break down production equipment; clean production areas; and maintain consumable supplies.

• Properly operates, sets‑up, and breaks down production equipment.
• Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area, and tool disinfection.
• Performs minor mechanical maintenance of equipment.
• Maintains consumable supply inventory.
• Washes small utensils and glassware for the department.
• Properly performs drug product manufacturing, packaging, and labeling activities under direct supervision.
• Follows written procedures.
• Distributes clinical supplies.
• Clearly and accurately documents activities for production records and manufacturing equipment (production notebooks, cleaning logs, maintenance logs, etc.).
• Performs basic math calculations.
• Assists with batch records for cGMP manufacturing under direct supervision.
• Other duties as assigned.

• Mechanical aptitude is preferred.
• Moderate knowledge of manufacturing equipment for a cGMP environment.
• Ability to wear Personal Protective Equipment (PPE); understand and follow safety procedures to avoid injury to self and co‑workers; willingness to work with highly toxic and controlled substances.
• Ability to conduct routine in‑process testing and visual inspections and identify out‑of‑specification conditions.
• Ability to work in a regulated environment (FDA/DEO/OSHA) and strictly follow procedures.
• Effective verbal and written communication; ability to read and comprehend detailed written instructions.
• Ability to clearly and concisely document all work activities in a timely manner utilizing existing forms and records; writes legibly.
• Perform basic math functions, including product accountability and material adjustment calculations; basic computer skills.
• Ability to move materials throughout the facility using appropriate methods and equipment.
• Operate machinery and read process control instruments to ensure proper operation; identify operational problems when they occur.
• Ability to clean rooms, equipment, and tools for use in a cGMP environment.
• Perform basic troubleshooting applications.
• Provide basic training to other operators after learning a skill set.
• Minimal interaction on an as‑needed basis.
• Exhibit leadership skill in the individual area of expertise.
• Must be able to work overtime when required.
• Must adhere to attendance policy; expected to arrive on time and contact management immediately if unavailable.
• May directly interact with auditors during a scheduled inspection.
• Ability to work effectively within a team environment.

• High school diploma or equivalent with 0–5 years of experience in a regulated environment.

The hiring range in Colorado for this position is $27/hr–$33/hr; base pay may vary depending on job‑related knowledge, education, skills, and experience of the applicant, internal equity, and market data. This range covers several levels and is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.

Cambrex is an Equal Opportunity / Aff‑Positive Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, veteran status, or disability status.

Works under limited supervision.

The employee is required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee frequently sits, occasionally stands, walks, and stoops. Regularly lift or move up to 10 pounds and occasionally up to 25 pounds. Specific vision abilities required. Reasonable accommodations may be made for individuals with disabilities.

The work environment characteristics include exposure to moving mechanical parts and vibration. Noise level is usually very quiet. Protective equipment will be required as specified by safety procedures.

Little to no expected travel time.