DESCRIPTION:
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 Relocation assistance is NOT provided.
Roles and/or Responsibilities:
- Participate in determining the packaging requirements according to the nature of the product, cost limitations, legal requirements and the type of protection required, taking into consideration the need for resistance to external variables. May independently design a more straightforward package.
- Participate with performing package characterizations including cost effectiveness studies.
- Generate and authorize project documentation involving equipment layouts, utility requirements, P&IDs, FAT and SAT, process change requests and data sheets.
- Author validation/qualification protocols for routine use; suggests improvements.
- Authors and executes validation/qualification protocols and engineering studies. Advises supervisor of factors that may affect experiment; suggests additional experiments.
- Maintains accurate records & training file in accordance with Division standard.
- Interacts with other departments, participates in project meetings, interprets results, and suggests next experiment.
- Participates in New Product Introduction (NPI) meetings and impacts business opportunities through successful completion of tasks and projects and through suggestions for improvement in products and processes.
- Provide technical support for software applications associated with packaging and labeling equipment.
- Monitor and collect data regarding systems performance and report to management. Identify existing problems and recommend solutions.
- Assist internal customers in identifying project specifications and system-related plant and equipment needs; assist in managing the transition of assigned projects to Systems Engineering.
- Participate in developing and revising operating equipment specifications and other policies and procedures as needed.
- Troubleshoot existing processes and recommend or design engineering solutions and/or equipment to address capacity, cost, and quality issues.
- Assess equipment status and identify risk of obsolescence, upgrade needs or potential productivity gains. Evaluate and implement necessary upgrades to maintain a world-class manufacturing environment.
- Knows and effectively uses the fundamental engineering concepts, practices and procedures.
- Proficiency in the use of basic engineering techniques, equipment and materials.
Minimum Requirements/Qualifications:
- B.S. Degree in engineering preferred (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 the following disciplines is useful: PLC/HMI programming, design software, microbiology, biological science, chemistry, technical writing, machinery, physics and statistics.
- 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 be able to pass a comprehensive background check, which includes a drug screening.
