Location: Carlsbad, CA

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Division Specific Information

At Microbial Material Services (MMS), a new Business Unit within Thermo Fisher Scientific’s Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

How will you make an impact?

Ensure process equipment deliveries, ISO-Class / EU Grade cleaning, and buffers & media deliveries in support of clinical and commercial GMP plasmids. Demands are met in accordance with established quality, efficiency and regulatory standards. The Engineer will manage planning, execution, and internal / external customer interactions for continuously improving the manufacturing operations process at the plant/site. S(he) will support manufacturing team on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. S(he) will work closely with colleagues in MST, PD, Quality, EHS, Commercial, and Manufacturing to ensure compliance, successful technology transfers and process improvements. This position will interface directly with external clients to provide expertise and process guidance.

What will you do?

• Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include chromatography, ultrafiltration, and depth filtration.
• Represent Process Engineering in Internal and Customer meetings and make sound evidence-based contributions.
• Manage projects with supervisor oversight
• Actively drive engineering initiatives to improve practices and procedures
• Provide technical support for GMP deviations. Help devise and Implement Corrective Actions.
• Implement changes to equipment and processes
• Document procedures via Process Flow Diagrams, Standard Operation Procedures, and Job Aids.
• Draft and own Manufacturing Batch Records ensuring the process is technically accurate and Designed for Manufacturing
• Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs
• Provide on-floor technical support for manufacturing processing, as needed.

How will you get here?

Education

• Bachelor’s degree in Engineering with 5 years industry experience in a cGMP environment or equivalent combination of education and experience
• Proficient with computers (MS Office). Working knowledge of controlled documentation and data systems.
• In depth knowledge of cGMP regulations.

Experience

• 5 + years within a GMP Environment

• 3 + years of experience in engineering

• Extensive knowledge of plasmid / microbial manufacturing processes and equipment
• Understanding and/or knowledge of change control and performing process impact assessments.
• Experience with process equipment for the following systems: fermenters, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.

Knowledge, Skills, Abilities

• Understands microbial production processes and the production environment
• Good understanding of cGMP and other regulatory requirements
• Mechanical & technical ability/aptitude
• Analytical problem-solving skills
• Good business decisions using both cost and risk analysis
• Good communication and presentation skills (verbal and written in English)
• Unquestionable integrity
• Lead change
• Handle multiple tasks, issues, projects
• Work independently and as a part of a team
• Build agreement via collaboration

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.