Manufacturing Associate I (Fremont, CA)
We are proud to offer an exciting long-term temp. opportunity to work as an Manufacturing Associate at a Pharmaceutical Company located in Fremont, CA.
Must have at least 1 year of Biotech Manufacturing experience working in a cGMP facility!
Long-Term Temp. Assignment (Possible Temp to Perm Opportunity!)
Pay Rate: $23 to 26.00/hour, depending on Education and Experience
Candidates must be flexible to work any shifts (day, swing or night shifts), including weekends and over time!
- Shifts are 10 hour shifts, 4 days a week from: Sunday-Wednesday OR Wednesday to Saturday. Flexibility is a must!
- 1st Shift: 6:00 am - 4:30 pm
- 2nd Shift: 2:00 pm - 12:30 pm
- 3rd Shift: 11:00 pm – 7:30 am
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.
- 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.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
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