Manufacturing Operator II - Day Shift

Thermo Fisher ScientificFremont, CA
Onsite

About The Position

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.

Requirements

  • High school diploma or equivalent required.
  • Minimum of 1 year of direct work experience in a manufacturing, operations, production, lab setting.
  • Comfortable using MRP systems, electronic document systems, and Microsoft Office (Word, Excel, PowerPoint).
  • Strong attention to detail with batch records, SOPs, inventory transaction.
  • 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.
  • Able to lift up to 40 lbs. without assistance.
  • 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

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

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.
  • Support process improvements, equipment validation, and Lean/PPI initiatives while working with cross-functional teams.
  • Perform other assigned duties as required.

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
  • 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
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