Sr. Operator, Manufacturing

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

About the role

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. The Sr. Operator Manufacturing 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.

Responsibilities

• 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
• Review batch records and work with cross-functional teams to resolve record discrepancies
• Provide equipment and process training for new employees per direction from production lead/management
• Actively engage in process improvements, support equipment validation, and Lean/PPI initiatives while working with cross-functional teams
• Perform other assigned duties as required

Requirements

• High school diploma or equivalent required
• Minimum of 3 years of direct work experience in manufacturing, operations, production, or lab setting
• Direct machine operation experience
• Direct experience in a cGMP environment, Good Documentation Practices (GDP), and Good Warehouse Practices
• Comfortable using MRP systems, electronic document systems, and Microsoft Office (Word, Excel, PowerPoint)
• Strong attention to detail with batch records, SOPs, and 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 figures required
• Ability to handle multiple tasks and respond effectively to changing priorities and deadlines
• Able to lift up to 40 lbs. without assistance
• Must be flexible to support overtime, weekend overtime, and swing shifts (4pm-4am) as production demand requires
• May require training for 6 months conducted from 6:00am - 2:45pm (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, or facial hair allowed
• Fluctuating temperatures (hot/cold)
• Laboratory setting
• 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 environment
• Will work with hazardous/toxic materials
• May work in cold environments (as low as -20°C) and around loud-noise equipment
• 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

Schedule

• 9:00 AM to 5:45 PM, Monday through Friday
• Must be flexible to support overtime, weekend overtime, and swing shifts (4pm-4am) as production demand requires
• May require training for 6 months conducted from 6:00am - 2:45pm (Mon - Fri)

Pay

Competitive hourly pay rate of $21.42 - $26.59/hr. Additional shift differential for 2nd and 3rd shift positions. Annual performance-based bonus and merit-based increase.

Benefits

• Medical, dental, and vision benefits effective on day 1
• Paid Time Off and designated paid holidays
• Retirement Savings Plan
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities
• Employee assistance and family support programs, including commuter benefits
• 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
• 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount