Transforming Biopharmaceutical Processing: Join Thermo Fisher Scientific as a Senior Process Engineer - Upstream
Thermo Fisher Scientific, a global leader in the biopharmaceutical industry, is seeking an experienced Senior Process Engineer with a focus on Upstream Biomanufacturing to join our dynamic team. As a Sr. Process Engineer - Upstream, you will play a critical role in shaping the future of biopharmaceutical processing technology and contributing to the development of innovative solutions that enable our customers to make the world healthier, cleaner, and safer.
About Us
Thermo Fisher Scientific is a renowned company that empowers its customers to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. With a global presence and a diverse team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - that drive our mission to enable our customers to make a positive impact on the world.
Role Overview
As a Senior Process Engineer - Upstream, you will be responsible for supporting the Process Engineering team as a technical owner of customer programs within a manufacturing environment. You will collaborate with cross-functional teams, including Operations, Quality Assurance, and Process Development Scientists, to drive project success and contribute to the advancement of biopharmaceutical processing technology. This role offers an exciting opportunity to work on cutting-edge projects, develop new methodologies, and shape the company's internal processes.
Key Responsibilities
- Draft, review, and approve Standard Operation Procedures, Job Aids, and other documents to ensure scientifically sound and robust procedures.
- Collaborate with process development teams to develop standardized methodologies and explore new approaches for conducting unit operations at the manufacturing scale.
- Contribute to internal and customer meetings, providing expert insights and evidence-based recommendations.
- Initiate and lead internal projects, manage timelines, and drive project success with minimal supervision.
- Identify opportunities for error proofing and drive engineering initiatives to improve practices and procedures.
- Provide scientific expertise for GMP deviations, assessing and reviewing the impact on product quality and process validation.
- Initiate and lead changes to equipment and process design, ensuring scientifically sound and robust processes.
- Act as a subject matter expert to troubleshoot design flaws, ensure process design is within validated process and regulatory guidelines, and review process data.
- Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
- Apply technical and functional knowledge to site projects, design experiments, and complete work within own discipline.
- Troubleshoot technical challenges on the manufacturing floor, supporting 24/7 operations.
- Support the MSAT team with additional tasks to improve site operations, ensure patient safety, and deliver for customers.
- Develop and train Process Engineers/Scientists, sharing knowledge and expertise.
Essential Qualifications
To be successful in this role, you will need:
- A Bachelor's degree in a scientific field, preferably an engineering field.
- 8+ years of experience in GMP regulated Biologics/Pharma Industry, or equivalent experience (or master's degree in a scientific field + 6 years' experience or Ph.D + 3 years' experience).
- Experience drafting, reviewing, and approving Manufacturing Batch Records, Process Validation Protocols, and other process-related documents.
- Knowledge of current Good Manufacturing Practices and US/EU regulations.
- Advanced understanding of risk assessments and data mining (Excel/JMP).
- Proficiency in Microsoft Word and Excel.
- Ability to work independently and as part of a team.
- Strong communication and teamwork skills.
Preferred Qualifications
To stand out in this role, you will ideally have:
- Advanced knowledge of statistical methods used for Pharmaceutical Process Analysis.
- Experience with process development and scale-up.
- Knowledge of biopharmaceutical processing technologies and trends.
What We Offer
Thermo Fisher Scientific offers a competitive remuneration package, including:
- A competitive salary and annual incentive plan bonus.
- Comprehensive healthcare and employee benefits.
- Opportunities for career growth and development.
- A dynamic and inclusive company culture that values integrity, intensity, innovation, and involvement.
- A chance to work on cutting-edge projects and contribute to the advancement of biopharmaceutical processing technology.
Our Culture
At Thermo Fisher Scientific, we pride ourselves on a culture that values diversity, inclusivity, and collaboration. Our colleagues are passionate about making a positive impact on the world, and we strive to create an environment that supports their growth and well-being. We believe in fostering a culture of integrity, intensity, innovation, and involvement, where everyone can thrive and contribute to our mission.
Why Join Us?
By joining Thermo Fisher Scientific as a Senior Process Engineer - Upstream, you will have the opportunity to:
- Work on cutting-edge projects that shape the future of biopharmaceutical processing technology.
- Collaborate with cross-functional teams and contribute to the development of innovative solutions.
- Develop new skills and expertise, and advance your career in a dynamic and supportive environment.
- Be part of a global community that values diversity, inclusivity, and collaboration.
- Make a positive impact on the world by enabling our customers to make the world healthier, cleaner, and safer.
How to Apply
If you are a motivated and experienced Senior Process Engineer with a passion for biopharmaceutical processing, we encourage you to apply for this exciting opportunity. Please submit your application today, and join our team of talented professionals who are shaping the future of the biopharmaceutical industry.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and welcomes applications from diverse candidates. We are committed to creating an inclusive environment that values diversity and promotes equal opportunities for all.
Apply Now