Manufacturing Technician (Drug Substance Manufacturing)

Job Description

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 healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Job 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.

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.

Qualifications/Skills

• 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.

Education, Experience & Licensing Requirements

• 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.

The hiring range in Colorado for this position is - however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.

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

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Supervision Received: Direct

Works under direct supervision. Relies on experience and judgment to plan and accomplish goals within defined procedures and practices. Seeks management direction for problems of diverse scope.

Travel: 0%

Physical and Environmental Demands:

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to sit; walk and stoop, kneel or crouch. The employee must regularly lift and/or move up to 50 pounds, frequently lift and/or move up to 60 pounds and occasionally lift and/or move up to 75 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Environment and Protective Equipment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must be able to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.