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Lead Manufacturing Associate in Sunnyvale, California at Cepheid

Date Posted: 5/10/2019

Job Snapshot

Job Description

Job ID: CEP003212

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

ESSENTIAL JOB RESPONSIBILITIES:

  • Understand and adhere to safety policies and practices
  • Follow Dry Room Procedures
  • Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR)
  • Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions.
  • Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures.
  • Set up and operate manufacturing equipment.
  • Clean and maintain equipment and work area.
  • Use tools such as microscopes, tweezers, and other hand-held tools.
  • Perform in-process inspection of components and assemblies to verify quality conformance.
  • Recognize any issues from the equipment and any affiliated documentations and take appropriate corrective action within scope. Notify Supervisors of issues and discrepancies immediately.  Communicate problems to manufacturing engineers.
  • Assist engineers with product transfer activities and bill of material corrections.
  • Report causes of process and/or documentation and assist or coordinate resolutions.
  • Perform several basic Manufacturing operations or some complex manufacturing operations proficiently.
  • Apply company policies and procedures to complete assignments.
  • Conduct Shift PASSDOWN with peers
  • Follow production schedules
  • Follow acceptance criteria for equipment yield and efficiency
  • Monitor machines for problems and troubleshoot minor ones.
  • Start and end batch runs
  • Email the Manufacturing Engineering group explaining any downtime problems/issues.
  • Perform label printing responsibilities
  • Review DHRs
  • Prepare and verify materials to be used as issued to work orders
  • Submit work order completions.
  • Understand and execute Line Clearance.
  • Perform set-up and change-over on equipment.
  • Train employees on products, processes and documentation.  Training includes new hire orientation on Good Manufacturing Practices (GMPs), safety and chemical handling.  Maintain training documentation.
  • Verify labels
  • Red-line documents for revision changes
  • Perform line set-up and verification according to SOPs
  • Work closely with the product transfer and engineering teams on process and equipment issues.
  • Provide timely notification to supporting groups (i.e., store shortage, manufacturing engineers, and process engineers) so servicing of line is performed in a timely manner.
  • Lead assigned shift
  • Interact with material planning team to understand the needs required to meet the production plan.
  • Understand all work requests, personnel support for these requests and effectively communicate schedules to Supervisor.
  • Assure GMPs, housekeeping, safety and environmental guidelines are being followed correctly and consistently.
  • Oversee movement of materials into clean rooms as well as movement of product out of clean rooms.
  • Ensure batch records are complete and accurate.
  • Identify and eliminate sources of inefficiencies.
  • Assist in daily analysis of scrap to identify training/improvement opportunities in manufacturing processes.
  • Prioritize production activities.

Job Requirements



Qualifications

MINIMUM REQUIREMENTS:

Education or Experience (in years): 

  • 6+ years of related experience
  • High School diploma/GED or equivalent experience
  • Experience in clean room assembly or Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience.
  • Experience in FDA or Kema audits

Knowledge and skills: 

  • Knows how to read drawings.
  • Understands GMP and Good Documentation Practice (GDP)
  • Must be a team player and able to demonstrate willingness and ability to provide assistance to anyone that needs assistance.
  • Ability to clearly and effectively communicate with peers, supervisors, engineers, managers, leads and upper management.  Able to understand any given instructions and batch records written and spoken in English.
  • Effective verbal and written communication skills
  • Ability to pay close attention to detail.
  • Basic Computer Skills
  • Ability to solve basic math problems
  • Able to identify each station of the machinery.
  • Able to contribute to the development of concepts and techniques.

Physical requirements/abilities: 

  • Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.
  • Ability to work directly with, handle or come into contact with chemicals or reagents.

PREFERRED REQUIREMENTS:

  • None


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.