Manufacturing Associate I

Job Description

Fremont, CA

Contract Duration: 6-24 months

Rate: Negotiable

Responsibilities:

Excellent employment opportunity for a Manufacturing Associate I in the Fremont, CA area.

Prepare a variety of media and stock solutions that are transferred from tank to bag or tank to tank in order to support cell culture main operations to facilitate proper cellular growth per SOP.

Able to follow SOP's to perform routine cleaning activities of parts and equipment using manual cleaning methods, designated parts washers, Clean-In-Place (CIP) and COP(Clean-Out-Of-Place) systems.

As well as collecting rinse water samples and performing swabs on required equipment for testing.

Execute proper documentation and measures to initiate changing over of parts and equipment to be released for use.

Performs a majority of operations in a cGMP clean room environment.

Practices ergonomic safety and use appropriate personal protective equipment (PPE) in all operations.

Documents execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).

Interchanging between electronic and paper documentation procedures.

Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

Reports any issues related to manufacturing performance, process and safety to the team lead or Manager in order to ensure safety and compliance with regulations and cGMPs and to facilitate continuous process improvement.

Participates in training and development opportunities in order to gain an understanding of SOPs.

Performs routine housekeeping of the manufacturing plant using the 5S organization methodology by using appropriate equipment safety signage, labeling of parts-in-process, sweeping water pools to the floor drain, and picking up parts from the floor.

Collaborates within team and department in order to follow best practices and meet department goals.

Experience:

Requires a High School Diploma or equivalent plus four (4) years closely related Technical experience, preferably in a Pharmaceutical or Chemicals Manufacturing environment.

An Associate's Degree with a minimum of two (2) years closely related Technical experience, preferably in a Pharmaceutical or Chemicals Manufacturing environment; or a Bachelors' Degree, preferably in a Science or Engineering field is preferred with 1+ years of GMP exp.

Experience working with established GMP procedures and bulk manufacturing.

Technical knowledge of manufacturing systems, methods and procedures.

Understanding of cell culture processes.

Demonstrated ability to be organized and work well in small work groups.

Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.

Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.

Demonstrated ability to read, comprehend, and follow written instructions.

Demonstrated written and verbal communication skills are required.

Experiences in related Biotechnology/Pharmaceutical industry strongly preferred

Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer-based software

Preferred skills: Current Good Manufacturing Practices, Mammalian cell culture, Bio Manufacturing Execution System (BioMES), Process Control System DeltaV, Laboratory Management Information System (LIMS) Physical Demands / Surroundings

Requires physical activity such as almost constant standing, walking, eyestrain, etc.

Must be able to occasionally lift up to 25 lbs.

Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.

Entry level in subject matter

Schedule: Sunday - Wednesday, 6:00AM - 4:30PM

Required Skills: CGMP

Additional Skills: MEDIA PREP, CLEAN ROOM, COMPUTER OPERATIONS, DELTAV, DETAIL ORIENTED, DOCUMENTATION, ENTRY LEVEL, INDUSTRIAL/MANUFACTURING, GMP, LABORATORY, LIMS, MAMMALIAN CELL CULTURE, MS OFFICE, OPERATIONS, OUTLOOK, PROCESS CONTROL, PROCESS IMPROVEMENT, INDUSTRIAL, FOOD INDUSTRY, PRODUCTION EQUIPMENT, SOP, SOPS, TRAINING, BATCH RECORD, CELLULAR, EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS, MAINTENANCE, MICROSOFT OFFICE, MICROSOFT OUTLOOK