Sr Manager Manufacturing Engineering, Bioproduction (Onsite

Sr. Manager, Manufacturing Engineering

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

Location:

This is an onsite position in Santa Clara, CA. Residecy near the location is required. Relocation assistance is not provided.

The Sr. Manager, Manufacturing Engineering leads the engineering function within the site, providing technical leadership across mechanical, electrical, automation, and NPI engineering teams. This role drives business performance by improving manufacturing processes, enabling new product introductions, and increasing capacity, quality, and efficiency. The position ensures compliance with GMP, regulatory, and quality standards while leading engineering strategy, innovation, and continuous improvement initiatives across the site.

• Mentoring engineers, delivering feedback, and defining roles / responsibilities to drive ownership and accountability
• Crafting personalized career development plans for each team member and finding opportunities and individual goals to support these development plans
• Provide innovative technical support and solutions to products and processes
• Support NPI and Life Cycle Management
• Support mechanical design and implementation on the manufacturing floor
• Perform failure investigations and CAPAs
• Provide frontline engineering support and first rate technical response to manufacturing
• Identify and implement methods to reduce cost, reduce scrap, and increase capacity
• Improve safety, quality, and production efficiency
• Engage across functions to share and implement the best manufacturing and procedural practices
• Generate manufacturing procedures and test documents for new equipment and processes
• Support customer and regulatory audits
• Work with and across all functions

Advanced Degree in an Engineering or Technical field with 10 years of experience in Manufacturing Engineering in a production environment and 6 years of leadership experience OR Bachelor's degree in and Engineering or Technical field with 12 years of experience in Manufacturing Engineering in a production environment and 6 years of leadership experience OR Associate's Degree in in an Engineering or Technical field with 14 years of experience in Manufacturing Engineering in a production environment and 6 years of leadership experience OR High School Diploma with 16 years of experience in Manufacturing Engineering in a production environment and 6 years of leadership experience.

Extensive experience in manufacturing/process engineering.

Experience leading engineering teams in production environments

Experience supporting NPI, process optimization and CAPA

Experience with various statistical analysis tools and methods

Experience in biopharmaceutical or regulated manufacturing (GMP, FDA, ISO) preferred

Experience with automation and advanced manufacturing technologies preferred

Strong knowledge of manufacturing, engineering principles and process optimization

Expertise in root cause analysis, CAPA and problem-solving methodologies

Strong leadership and team development capability

Ability to influence cross-functional stakeholders

Strong project and program management skills

Experience with lean manufacturing and continuous improvement methods and philosophies

Experience with engineering standards, testing, SPC, and FMEAs

Strong communication and technical writing skills

Proficiency in DOE and FEA and associated software tools.

Experience in GMP/FSA/ISO regulated environments

Willingness to travel as required (