Manufacturing Operator II

Longmont, Colorado, United States Full-time

Position Title: Manufacturing Operator II – Drug Product (Solid Dose)
Job Location(s):  Longmont, CO
Start Date: ASAP
Employment Type: Full-Time; Hourly Non-exempt
Starting Salary Range: Competitive
Job Requisition #: 180108

Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. We are currently accepting resumes.

The Manufacturing Operator II will properly operate solid dose manufacturing equipment to perform production of drug products. Personnel in this position will operate manufacturing processing equipment by following standard operations procedures and batch records in accordance with FDA cGMPs. The main focus for personnel in this position will be responsible to operate, set-up and break down production equipment, clean production areas and maintain consumable supplies.

Duties:

  • Properly operates, sets-up and breaks-down production equipment.
  • Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area and tools and equipment disinfection.
  • Performs minor mechanical maintenance of equipment.
  • Maintains consumable supply inventory.
  • Washes small utensils and glassware for 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)
  • Perform basic math calculations.
  • Assists with batch records for cGMP manufacturing under direct supervision.
  • Other duties as assigned.

Qualifications:  

  • High school diploma or equivalent with 5+ years of experience in a regulated environment.
  • Mechanical aptitude is preferred
  • Moderate knowledge of manufacturing equipment for cGMP environment

Success Factors:

  • Ability to wear Personal Protective Equipment (PPE). Understands and follows safety procedures and works in a manner 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.
  • Effectively communicates both verbally and in writing. Ability to read and comprehend detailed written instructions.
  • Ability to clearly and concisely document al work activities in a timely manner utilizing existing forms and records. Writes legibly.
  • Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills.
  • Ability to move materials throughout facility using appropriate methods and equipment.
  • Operate machinery and read process control instruments to ensure proper operation. Identify operations 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.
  • Exhibited leadership skill in individual area of expertise.
  • Must have the ability to work overtime when required.
  • Must adhere to attendance policy of Avista. Expected to arrive for shift on time and contact management immediately if unable to attend work for any period of time.
  • May directly interact with auditors during a scheduled inspection.
  • Ability to work effectively within a team environment.

Physical and Environmental 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 position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this position, the employee must regularly stand and bend, and climb; and is frequently required to sit and walk, crawl, stoop. Employee must frequently use hands to finger, handle or feel objects, tools or controls.  Must be able to talk and hear. Employee must frequently lift and/or move up to 75 pounds and able to move drums or pallets of up to 2,400 pounds with use of drum truck, pallet jack, or fork lift.  Specific vision ability required by this job includes close vision, distance vision, depth perception, and the ability to adjust focus, and observe color changes.

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.