Engineer II, Manufacturing Engineering

Join our collaborative team as a Manufacturing Engineer II at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. In this role, you'll be responsible for ensuring compliance, quality, and operational excellence across our facilities through comprehensive validation activities. Working with advanced technologies and diverse teams, you'll help maintain high standards in pharmaceutical manufacturing, laboratory operations, and quality control.

Location: Fremont, CA

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards
• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed
• Cold Room/Freezers: -22°F / -6°C
• Laboratory Setting
• Loud Noises (Equipment/Machinery)
• No contact lenses allowed; prescriptive glasses will be provided
• Office environment
• Personal Protective Equipment (PPE) required: safety glasses, gowning, gloves, lab coat, ear plugs, etc.
• Standing for full shift
• Strong Odors (chemical, lubricants, biological products, etc.)
• Warehouse

Responsibilities

• Participate in determining packaging requirements based on product nature, cost limitations, legal requirements, and protection needs, including resistance to external variables
• Independently design straightforward packaging solutions
• Perform package characterizations, including cost-effectiveness studies
• Generate and authorize project documentation, such as equipment layouts, utility requirements, P&IDs, FAT and SAT, process change requests, and data sheets
• Author validation/qualification protocols for routine use and suggest improvements
• Author and execute validation/qualification protocols and engineering studies; advise supervisor on factors affecting experiments and suggest additional experiments
• Maintain accurate records and training files in accordance with division standards
• Interact with other departments, participate in project meetings, interpret results, and suggest next steps
• Participate in New Product Introduction (NPI) meetings and impact business opportunities through task completion and process improvements
• Provide technical support for software applications associated with packaging and labeling equipment
• Monitor and collect data on systems performance, report to management, identify problems, and recommend solutions
• Assist internal customers in identifying project specifications and system-related plant and equipment needs; manage project transitions to Systems Engineering
• Participate in developing and revising operating equipment specifications and other policies/procedures
• Troubleshoot existing processes and recommend or design engineering solutions to address capacity, cost, and quality issues
• Assess equipment status, identify risks of obsolescence, upgrade needs, or potential productivity gains; implement necessary upgrades
• Apply fundamental engineering concepts, practices, and procedures proficiently
• Use basic engineering techniques, equipment, and materials effectively

Requirements

• B.S. Degree in engineering (mechanical, electrical, industrial, or design preferred) or related scientific discipline with a minimum of 2–5 years of relevant industry experience
• College and/or technical training in PLC/HMI programming, design software, microbiology, biological science, chemistry, technical writing, machinery, physics, or statistics is useful
• Working knowledge of labeling and packaging equipment is preferable
• Computer skills; knowledge of Zebra printers and CIvision systems is desired
• GMP and experience working in a regulated industry
• Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
• Must be legally authorized to work in the United States without sponsorship
• Must pass a comprehensive background check, including drug screening

Pay

The salary range estimated for this position based in California is $79,200.00–$105,600.00. 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.

Benefits

• A choice of national medical, dental, and vision plans, 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, life, short-term, and long-term disability insurance in accordance with company policy
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offering the opportunity to purchase company stock at a discount