Sr. Operator, Manufacturing - Day Shift

Thermo Fisher Scientific•Fremont, CA

1d•$21 - $29•Onsite

About The Position

The Sr. Operator position will interact and work closely with production leads and managers within the Manufacturing Services department to support production demand and ensure achievement of company goals following the 4i values. This position is based at the Fremont, CA site within the Niche Diagnostics Division (NDX), supporting diagnostic kit manufacturing in a cGMP environment. The position will work as an authorized user handling DEA-controlled substances (Schedules I–V), requiring strict adherence to DEA, FDA, and Thermo Fisher regulatory guidelines.

Requirements

High school diploma or equivalent required.
Minimum of 3 years of direct work experience in manufacturing, operations, production, lab setting.
Direct machine operation experience.
Direct experience in a cGMP environment, Good Documentation Practices (GDP), and Good Warehouse Practices.
Knowledge of Microsoft Word and Excel required.
Ability to use electronic management systems such as QAD and Oracle to print required documents and complete daily work as indicated in the production schedule.
Ability to read and write English.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to understand and carry out instructions furnished in written, oral, or diagram form.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to handle multiple tasks and respond effectively to changing priorities and deadlines.
Must be highly collaborative in a team-based work environment.
Able to lift up to 40 lbs. without assistance.
Work may involve exposure to cold environments and loud equipment.
Personal protective equipment (PPE) such as lab coats, gloves, safety glasses, and ear protection required.
This role involves handling, management, and oversight of controlled substances (Schedules I–V) in accordance with DEA, FDA, and Thermo Fisher guidelines.
Proper safety protocols and protective measures must be strictly followed.
Adherence to all safety procedures is mandatory to ensure a safe working environment.

Nice To Haves

Machine operation experience preferred.

Responsibilities

Responsible for signatures and reviews on SOPs and other work instruction documents.
Understand and communicate workflow and technologies used in the production environment.
Manufacture and/or test complex products following cGMP and complete all required documentation in accordance with the Quality System. Record information such as weight, time, and date packaged.
Share standard processes and train Operator I and II employees.
Set up and operate production floor equipment, including troubleshooting and adjustments under the direction of a Production Operator Lead or Supervisor.
Start, stop, and control the speed of conveyors.
Read and understand work orders to successfully set up materials on-line, verify, and count amounts required as per work order.
Inspect material, products, and containers at each setup of the production process.
Assist the Production Operator Lead in job assignments and provide guidance to other production operators as required.
Insert or pour product into containers or fill from spout or chute.
Acquire and sort product.
Wrap protective material around product.
Weigh containers and adjust quantity.
Close and seal containers; sort, label, and tag containers or products.
Pack special arrangements or selections of product.
Make necessary entries in the QAD system related to material usage.
Perform Line Clearance — responsible for reconciliation and disposal of materials related to the job.
Clean and sanitize work areas, machines, glassware, or equipment as needed.
Work with Production Leads, Operator II’s, and Operator I’s as a team to address scheduling, equipment, and logistics issues.
Support Engineering in process improvement and equipment validation activities.
Follow ISO/cGMP Quality System Regulations with focus on SOP accuracy, product quality, and housekeeping activities.
Participate in Practical Process Improvement (PPI), Lean, and 5S programs while working with other departments to troubleshoot processes and deliver recommended solutions.
Perform other job duties as required by the department and/or management.

Benefits

Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Employee Referral Bonus
Career Advancement Opportunities
Competitive Hourly Pay Rate
Additional shift differential for 2nd shift and 3rd shift positions
Annual performance-based bonus
Annual merit performance-based increase
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount