Employment Type : Full-Time
Job Title: Manufacturing Associate V/Lead
Job Location: Sunnyvale, Ca
Date Written: May 6, 2019
Written By: Lyndsey Clogston
Job Profile (Level-Job Family): O4 – Production Operations
POSITION SUMMARY:
Perform several manufacturing functions within the operation manufacturing team. Work on complex assignments requiring independent judgment and high degree of initiative to resolve issues. Identify and make recommendations for new procedures and improving equipment. Act as facilitator and highly skilled team leader for the department. Provide leadership and support in ensuring quality, lowering cost and improving productivity in production.
ESSENTIAL JOB RESPONSIBILITIES:
Understand and adhere to safety policies and practices
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 dry room and cleanroom standards, practices, and housekeeping according to standard operating procedures.
Set up and operate manufacturing equipment. Monitor machines and inform Supervisor and/or Lead of problems. Clean and maintain equipment and work area as needed.
Assist Senior Operators
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 minor issues from the equipment and any affiliated documentations and take appropriate corrective action within scope. Notify Supervisors and Leads of issues and discrepancies immediately.
Report causes of process and/or documentation and assist or coordinate resolutions.
Apply company policies and procedures to complete assignments.
Conduct Shift PASSDOWN with peers
Start and end batch runs. follow production schedules
Follow acceptance criteria for equipment yield and efficiency
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.
TRAINING RESPONSIBILITIES: (REQUIRED)
Complete all assigned and required training satisfactorily and on time
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
MINIMUM REQUIREMENTS:
Education and Experience (in years):
5+ 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:
Ability 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.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.