Biopharmaceutical Manufacturing Associate Jobs in San Ramon, CA

Work Schedule

Environmental Conditions

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.

How You Will Make an Impact:

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.

What will you do?:

· 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

Education & Experience:

· 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

Knowledge, Skills, Abilities:

· 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 (<10% anticipated)

Physical Requirements and Work Environment:

· Combination of office, lab, and manufacturing floor environment

· Frequent walking and interaction with production and engineering teams

· Occasional standing during testing, validation, and floor support activities

· Ability to lift up to 40 lbs occasionally

· Exposure to cleanroom, lab, and production environments requiring PPE

· Use of engineering tools, equipment, and computer systems

· Occasional travel (<10%) as required

Compensation and Benefits

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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards