Manufacturing Associate - 3rd shift in Fremont, CA at Apex Life Sciences

Date Posted: 10/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fremont, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    10/2/2018
  • Job ID:
    891318

Job Description


Apex Life Sciences is seeking a Manufacturing Associate to work on an overnight position Wednesday through Saturday

Responsibilities:

  • Performs production processes for GMP manufacturing operations.
  • Operates large-scale and small-scale bioprocess equipment for purification processing.
  • Executes routine unit operations in Purification related to the manufacturing of bulk drug substance in a multi-product facility, as assigned. This may include tank CIP/SIP, transfer, harvest, chromatography, and tangential flow filtration.
  • Performs duties under limited supervision and according to standard operating procedures and batch records.
  • Executes routine unit operations in Purification such as chromatography, tangential flow filtration, Clean-In-Place (CIP), and Steam-In-Place (SIP) operations.
  • Practices ergonomic safety and uses appropriate personal protective equipment (PPE) in all operations.
  • Performs in-process analytical instrument measurements e.g. pH, conductivity, temperature, pressure, among others.
  • Documents execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).
  • Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
  • Escalates to the team lead or Manager any manufacturing performance, process, or safety issues to ensure safety, regulation compliance, and to facilitate continuous process improvement.
  • Adherence to GMP training schedule and responsible for achieving all training requirements within acceptable timelines.
  • Performs routine housekeeping of the manufacturing plant using the appropriate equipment safety signage, labeling of in-process parts & equipment, squeegeeing liquids to the floor drains, and picking up parts that have fallen on the floor.
  • Performs unit operations described in standard operating procedures and batch records.
  • Recognizes and proactively corrects errors in bioprocess operations prior to failure.
  • Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.
  • Performs review of GMP documentation.
  • Completes required processing documentation, including product change over and other documentation.
  • Reviews and signs executed process and solution MBRs.
  • Ensures acceptable quality and quantity of work executed.
  • Ensures that standard operating procedures (SOPs) are followed and are correct for bioprocess operations and equipment.
  • Ensures compliance with company quality systems, safety procedures, and other company policies.
  • Demonstrates good judgment in applying industry practices and company policies to daily operations. Performs other duties as assigned.

Qualifications

  • 1+ years of experience in a biotech manufacturing environment or other regulated cGMP manufacturing facility and a Bachelor’s degree in science related area or engineering or Associate’s degree in science related area or Biotech certificate or in lieu of Education requirements 3 years of experience in cGMP manufacturing environment.
  •   Competency with process equipment and automated control systems
  • Working experience with GMP manufacturing regulations.  
  • Working knowledge of manufacturing equipment and technology
  • Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation
  • Experience in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
  • Ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position.
  • Communication abilities:  to read, speak, and write legibly in English.
  • Proficiency in computer skills, including work with spreadsheet programs (Excel) and word processing (Word).
  • Effective time management skills.
  • Detail orientation with the ability to complete written and verbally assigned tasks following specific instructions and procedures.
  • Ability to interact constructively with peers and support groups.
  • Organizational and communication skills necessary to ensure daily work plan is executed

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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