Description :
Job Title API (chemical) Manufacturing Technician
External Job Description The Hospira Boulder Operation is an API (active pharmaceutical ingredient) GMP Manufacturing facility of approximately 100 employees. We operate a 24/7 manufacturing schedule with 12 hours production shifts with 4 - 6 other manufacturing operators.
Our primary production is an oncology API known as Paclitaxel however site is continuing to add additional generic API's into manufacturing.
A successful candidate will be interested in working in a chemical manufacturing environment and able to mutli-task, work independently within strict cGMP guidelines, be flexible and willing to help in all areas needed. Attention to detail, thoroughness and integrity highly valued. This position is on the 2nd shift (5:45 pm to 6:15 am) and will work a 3-2-2-3 schedule, this would include working every other weekend. Successful candidates will be required to have a full background check, drug test and pre-employment physical.
Job Summary/Goals:
Responsible for performing a variety of small (10 kg batch size) generic API (active pharmaceutical ingredient) manufacturing tasks (rotovaping, chromotography, distillation, filtration, crystalization, drying, packaging, and misc. chemical reactions) and activities related to advancing the product through various processes to achieve prescribed level of purity, quality and consistency. Works within closely defined processes and fills out process documentation as required.
Essential Functions:
1. Receives training in process tasks, scientific theory and process documentation in order to become qualified under cGMP guidelines to perform generic API pharmaceutical manufacturing tasks. Level and complexity of training increases with demonstrated ability and successful task completion.
2. Performs process manufacturing tasks including operation of small and large scale equipment, weighing, measuring, monitoring of raw and in-process materials to assure batches contain proper ingredients, quantities and process output.
3. Prepared batches of solvents of other process ingredients as required.
4. Performs and monitors multiple process tasks simultaneously in order to most efficiently drive product through production steps.
5. Identified and informs supervisor of equipment malfunctions or process outputs that do not meet expected outcomes. May perform trouble-shooting of equipment or process problems and recommend solutions.
6. Fills out process documentation timely and accurately as required by SOPs. Writes up instances where process failures occurred.
7. Maintains manufacturing areas to identified standards of cleanliness and neatness; may involve sweeping, mopping floors, wiping down equipment, placing glassware and utensils in sterilizer, carrying away and appropriately disposing of trash.
8. Performs any related hazardous waste duties in accordance with internal controlled documents, local, State and Federal Regulations.
Skills/Experience Education/Certification Education: High school diploma or GED; college course work in science highly desirable.
Years of Experience: 2+ years of experience in chemical or pharmaceutical process operations.
Other: Mechanical aptitude and ability to use hands and tools to operate small/large-scale equipment; ability to effectively read and understand SOPs; ability to write sufficiently to fill out documentation and write about events clearly and concisely. Interpersonal skills sufficient to communicate effectively with co-workers and supervisors and to act in concert with others to achieve tasks.
Requires understanding of basic math skills to do mathematical calculations (i.e., weigh materials, calculate percentages).
Regularly engages in restricted manufacturing area activities. Hazardous environment with risk of exposure to chemicals, fumes, and heat and cold. Requires the ability to lift and carry up to 50 pounds; ability to crawl, climb, read, twist torso and stand for long periods of time. May need to push/pull material handling equipment up to 300 lbs.
State CO
Site Boulder CO
Location/Building BL (Boulder)
Job Family Manufacturing & Operations
Job Category Full Time
Shift Third
Start Time 5:45 pm
Stop Time 6:15 am
Auto req ID 5162BR
