11 Apr, 2022

Process Engineer III

  • Thermo Fisher Scientific
  • Carlsbad, CA, USA
Process Engineer Chemicals

Job Description

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! Our work will have real-world impact, and you will be supported in achieving your career goals!


Location/Division Specific Information:


We 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 ground breaking Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.


Potential to Make an Impact:


We 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 lead 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 MSAT, PD, Quality, EHS, Commercial, and Manufacturing to ensure compliance, successful technology transfers and process improvements. This position will interact directly with external clients to provide expertise and process guidance.


Scope of Responsibilities:

  • Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include fermentation, cell lysis, chromatography, ultrafiltration, and depth filtration.
  • Represent Process Engineering in Internal and Customer meetings and make sound evidence-based contributions.
  • Lead projects with supervisor oversight
  • Actively drive engineering initiatives to improve practices and procedures
  • Provide technical guidance 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.
  • Review and contribute to documents created by other departments, such as Tech Transfer Protocols, Equipment Preventive Maintenance Procedures and SOPs
  • Provide on-floor technical support for manufacturing processing, as needed.


Candidate Qualifications:

  • Bachelor’s degree in Engineering with 5 years proven experience in a cGMP environment or equivalent combination of education and experience
  • Proficient with computers (MS Office). Solid understanding of controlled documentation and data systems.
  • In depth knowledge of cGMP regulations.
  • 3 + years within a GMP Environment
  • 5 + 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/proficiency
  • 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
  • Balance multiple tasks, issues, projects
  • Work independently and as a part of a team
  • Build agreement via collaboration

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