Description

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. 

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.

Disclosures

Compensation

The hiring range in Colorado for this position is $31.80/hr-$35,65/hr and is eligible for 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 but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.  

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

How and When to Apply

If you are interested in applying, please click apply in this job posting.

Recruiting for this role is ongoing

#LI-SK1

PI283138834