Machine Operator

1 week ago

Fremont, United States Fladger Associates Full time

Responsibilities:

- Excellent employment opportunity for a Fill Finish in the Fremont, CA area.
- Ability to independently and accurately prepare all assigned records, calculations, and documentation.
- Demonstrated ability to independently and properly handle and dispose of hazardous waste.
- Ability to read and follow schedules, procedures, and documents.
- Demonstrated knowledge of safety precautions and procedures.
- Will be required to assist in training other employees in an area of responsibility as assigned.
- Assist staff in developing new procedures and methods or improving old ones.
- Ability to practice aseptic technique independently.
- Ability to perform media fills with (process simulation testing) with passing results per applicable SOP.
- Ability to perform clean room gowning and pass clean room garment validation consecutively.
- Ability to independently prepare disinfectants and sanitizing solutions.
- Ability to independently clean and sanitize production equipment, rooms and areas.
- Demonstrated knowledge of aseptic operation and the relationship of laminar flow systems and environmental monitoring.
- Ability to assist in performing environmental monitoring, such as but not limited to, independently placing settling plates and air sampling.
- Ability to use basic hand tools.
- Ability to independently set-up, operate, maintain, and troubleshoot steam sterilizers, capping machines, stoppering machines, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, L bar sealers/Bundler, vision systems, inkjets, vacuum check equipment as needed.
- Ability to wear a respirator if required for the job, no pulmonary restrictions.
- Ability to independently use and understand computer assisted data entry.
- Ability to independently perform sterile filtration.
- Ability to aseptically gather and transfer samples for QC testing.
- Ability to independently perform filter integrity and prepare accurate documentation.

**Experience**:

- High School Diploma or GED
- Demonstrated ability to lift fifty (50) pounds.
- Demonstrated knowledge of Federal, State, and international regulations, such as cGMP, USDA, DOT, EPA, OSHA as they pertain to the employee’s work.
- Demonstrated knowledge of corporate guidelines and Policies related to the employee’s work.
- Demonstrated knowledge of Standard Operating Procedures (SOPs) related to the employee’s work.
- Demonstrated knowledge of Material Safety Data Sheets (MSDSs), safety procedures, and hazardous materials procedures.
- Demonstrated knowledge of aseptic processing procedures related to the employees work.
- Demonstrated knowledge of team process and leadership principles.
- Demonstrated knowledge of appropriate processes and theory related to the employee’s work.
- Demonstrated knowledge of documentation related to the employee’s work.
- Demonstrated knowledge of equipment as defined in Duties Additional education and/or equivalent experience.
- Successful completion of National Career Readiness Work Keys assessment.
- Knowledge of Traffic Patterns.
- Knowledge of or evidence of working with BPE Methods.
- Understanding of Basic GMP/Documentation practices.
- Demonstrated ability and understanding of safe working habits.
- Ability to work in a team environment.
- Schedule: 3rd Shift: Sunday to Thursday, 10:00PM-6:30AM
- Required Skills: FILTRATION, ASEPTIC PROCESSING, VISION SYSTEMS, ASEPTIC TECHNIQUE, ENVIRONMENTAL MONITORING
- Additional Skills: ASEPTIC, DOCUMENTATION, STERILE, DOT, GMP, DATA ENTRY, SOP, EPA, CGMP, OSHA, SOPS, QC TESTING, CLEAN ROOM, AIR SAMPLING, USDA, PROCESS SIMULATION, HAND TOOLS, VACUUM, LOCKOUT/TAGOUT

**Job Type**: Contract

Schedule:

- Night shift

Work Location: In person

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