Sterile Filling Operator

Location: Irwindale, CA
Department: Azzur Solutions, LLC

Job Description

LEVEL 2: Packaging, autoclaving, cleaning, sterile filling, equipment set up.


Job Description:

The sterile filling operator will work closely with other production personnel in classified clean rooms (ISO 5 and 6) to fill sterile bulk product during filling operations. Batch production records and SOPs will be followed to perform related duties. The duties include but will not be limited to:
 Works closely with other departments to ensure that batch production is completed in a safe, compliant, and timely manner
 Wears proper personal protective equipment and follows aseptic procedures when gowning, degowning and working in the sterile and controlled areas.
 Preparation of cleaning solutions
 Cleaning of compounding/processing rooms and other critical surrounding areas
 Cleaning and sterilization of ancillary equipment  Cleaning and setting up of filling equipment
 Prepares equipment by performing cleaning-in-place (CIP), steam-in-place (SIP), and cleaning out-of-place (COP) procedures. Completes all necessary cleaning and preventative maintenance checks including filter integrity testing.  Operates and monitors batching equipment; observing and recording varying conditions; adjusting equipment and controls; conducting dilutions and yield calculations and following all relevant procedures.
 Adheres to production schedules and ensures that all tasks are performed in a timely manner.
 Completes all related bath production documentation  Troubleshoots basic production related issues such as raw material discrepancies, equipment problems, etc.
 Documents all activities as they occur in log books and Production dockets as required. Maintains cleaning logs per SOP requirements.
 Aids management for investigations or studies
 Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
 Assists with the training of new operators as required on the packaging line and filling line.

Education:
High school diploma GED or College Diploma in Sciences or BSc

Experience:
 2-4 years Technical:
 Must be able to perform calculations using simple mathematical formulas using fractions, percentages.
 Good command of the English Language. Must be able to read, understand, follow and comply with technical and written documents and processing instructions as well as clearly and accurately document all required information into batch documents.
 Mechanical aptitude required in order to operate PLC, HMI and labeling machine.
 Must be able to work around chemicals such as acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
 Classified clean room and gowning experience.  Manufacturing experience in a GMP environment. Pharmaceutical production experience is highly preferred.
 Autoclaving experience – such as wrapping items using autoclaving material, setting up loads for autoclave.
 Packaging experience – such as doing needed paper work for labels, inserts and boxes.
 Physical requirements include stooping, bending, standing, climbing and lifting of between 20 kg – 30kg. Must be able to work while wearing full protective gowning for entire shift. 

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

 



Apply Now

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