Manufacturing Operator II

ThermoFisher Scientific; Fremont (CA); On-site; USD 26,000 - 40,000; Full time

Benefits offered by this job

Competitive pay

Bonus eligibility

Total rewards package

Job summary

Thermo Fisher Scientific in Fremont, CA is seeking an Operator II to support production in the NDX division. The role involves reading work orders, setting up lines, operating fillers/labelers, and ensuring quality through documentation and inspections.

The position requires at least 1 year in manufacturing, GMP familiarity, GDP, and strong English reading/writing. The shift is 6:00 AM to 2:45 PM, Monday–Friday, with overtime as needed, and a comprehensive benefits package including annual merit

Qualifications

• Minimum 1 year of direct work experience in manufacturing, operations, production, or lab setting.
• Direct experience in a cGMP environment and Good Documentation Practices (GDP).
• Proficient in reading and writing English and following safety rules.

Responsibilities

• Read work orders, verify materials, and set up the production line with correct quantities and components per SOPs.
• Operate, monitor, and troubleshoot production equipment and conveyors to maintain efficient workflow.
• Manufacture and test products while completing documentation and performing quality inspections.
• Fill, seal, label, and organize products; perform line clearance and disposal of materials as needed.
• Clean and sanitize work areas and equipment to maintain a safe, compliant environment.
• Follow ISO/cGMP/GDP and Quality System regulations; communicate updates at shift end.
• Support process improvements and cross-functional Lean initiatives.

Skills

Attention to detail

Clear communicator

Reading/writing English

Task management

Education

High School Diploma or equivalent

Tools

MRP systems

Electronic document systems

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc), Warehouse, Will work with hazardous/toxic materials, Working at heights

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Pay: $19 - $26 per hour

Location/Division Specific Information:

This position is based at the Fremont, CA site within the Niche Diagnostics Division (NDX).

Standard Shift: 6:00AM to 2:45PM, Monday Through Friday

Must be flexible to support overtime, weekend overtime as production demand requires.

Must be flexible to support swing shifts hours (4pm-4am) as production demand requires.

How Will You Make an Impact?

The Operator II position will interact and work closely with peers, senior operators, production leads and managers within Manufacturing Services department to support production demand and ensure achievement of company goals following the 4i values.

A Day in the Life:

• Read work orders, verify materials, and set up the production line with correct quantities and components per manufacturing SOPs


• Operate, monitor, and troubleshoot production equipment (fille/labeler), printers, and conveyors to maintain efficient workflow


• Manufacture and/or test complex products while completing required documentation and performing quality inspections throughout the process


• Fill, seal, label and organize products, including handling special arrangements as needed


• Perform line clearance, including reconciliation and disposal of materials for each job.


• Clean and sanitize work areas, equipment, glassware to maintain a safe and compliant environment


• Follow direction from production lead/management and collaborate with team members to complete assigned tasks, resolve issues, and keep production running smoothly.


• Follow ISO/cGMP/GDP and Quality System Regulation to ensure all documentation is complete, workspace is organized, and key updates are communicated at the end of each shift.


• Support process improvements, equipment validation, and Lean/PPI initiatives while working with cross-functional teams


• Perform other assigned duties as required.

Education:

High school diploma or equivalent required.

Experience:

Required: Minimum of 1 year of direct work experience in manufacturing, operations, production, lab setting.

Preferred:

Direct experience in a cGMP environment, Good Documentation Practices (GDP), and Good Warehouse Practices.

Direct machine operation experience.

Knowledge, Skills, Abilities:

• Comfortable using MRP systems, electronic document systems, and Microsoft Office (Word, Excel, PowerPoint).


• Strong attention to detail with batch records, SOPs, inventory transactions.


• Clear communicator across peers, and management.


• Ability to understand and adapt to changes in production priorities and schedules.


• Ability to collaborate effectively within a team-based environment.


• Ability to read/write English and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals; and carry out manufacturing 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. Knowledge of significant figure required.


• Ability to handle multiple tasks and respond effectively to changing priorities and deadlines.

Physical Requirements / Work Environment

• Able to lift up to 40 lbs. without assistance.


• May work in cold environments (as low as -20C) and around loud-noise equipment.


• Personal protective equipment (PPE) such as steel-toe shoes, lab coats, gloves, safety glasses, and ear protection required.


• Controlled Substance Handling: This role involves handling, management, and oversight of controlled substances (Schedules I–V) in accordance with DEA, FDA, and Thermo Fisher guidelines.


• Exposure to Controlled Substances: Proper safety protocols and protective measures must be strictly followed.


• Safety Protocols: Adherence to all safety procedures is mandatory to ensure a safe working environment.


• Background Check: Successful completion of a background check, including screening related to controlled substances, is required.

What We Offer:

Thermo Fisher Scientific offers competitive pay, performance related bonus where eligible, annual merit performance-based increase, strong benefit package and career advancement opportunities. Our culture is built on Integrity, Intensity, Innovation, and Involvement.

Compensation and Benefits

The hourly pay range estimated for this position based in California is $19.69–$29.53.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs


• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.