Engineer II, Manufacturing Engineering

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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
-22degrees

F/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, 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

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.

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…