Sr. Manufacturing Process Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Our Mission is to enable our customers to make the world healthier, cleaner and safer.  Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing productivity in their laboratories, we are here to support them.

 

Location/Division-Specific Information:

Carlsbad, CA. Relocation assistance is NOT provided. 

*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 screen.

Discover Impactful Work:

As a Sr. Manufacturing Process Engineer, you will play a critical role in ensuring the efficiency, productivity, and quality of our biologics manufacturing processes. You will lead efforts to enhance process efficiency, scalability, and product quality through process optimization, troubleshooting, and continuous improvement initiatives.  Your expertise in process design, troubleshooting, and project management will contribute to the success of our operations.

A Day in the Life:

• Develop and optimize upstream and downstream bioprocess manufacturing operations—including fermentation, cell culture, purification, and antibody conjugation—to improve efficiency, robustness, and product quality.
• Support technology transfers, scale-up activities, and process characterization studies.
• Conduct process validation studies, analyze data, and implement corrective actions to ensure process stability and compliance with regulatory standards.
• Collaborate with cross-functional teams to drive continuous improvement initiatives, reduce costs, and enhance product quality.
• Utilize statistical tools and methodologies to analyze process data, identify trends, and implement appropriate process controls.
• Lead root cause analysis and troubleshooting efforts to resolve process-related issues and implement preventive measures.
• Provide technical guidance and support to production teams, ensuring adherence to standard operating procedures and best practices.
• Collaborate with equipment vendors and suppliers to evaluate new technologies and equipment to optimize processes and improve efficiency.
• Develop and maintain documentation, including work instructions, standard operating procedures, and process specifications.
• Stay updated with industry trends, advancements, and regulatory requirements related to manufacturing processes and technologies.
• Participate in cross-functional projects and initiatives to drive process improvements and operational excellence.

Keys to Success:

Education and Experience

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Molecular Biology, or related STEM field required.
• 5+ years focused on process optimization and improvement, or an advanced degree plus 3 years of experience.
• Strong knowledge and experience in process design, validation, root cause analysis, and troubleshooting.
• Hands-on experience supporting fermentation, bioreactors, protein purification (chromatography, TFF), and/or conjugation processes preferred.
• Proficiency in statistical analysis tools and methodologies.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Excellent problem-solving and analytical skills.
• Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously.
• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
• Detail-oriented with a focus on accuracy and quality.
• Familiarity with regulatory requirements, GMP, and ISO standards in the manufacturing industry.

 

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in California is $91,700.00–$110,000.00.

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. 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