Process Engineer

San Diego, CA
Nov 13, 2020
Required Education
Bachelors Degree
Position Type
Full time

BioSpace has been engaged with our client, San Diego biopharmaceutical company who develops vaccines and antibody therapeutics for infectious diseases, opioid overdoses, and provides medical devices for biodefense purposes.

The Process Engineer will be a supporting member of the Process Development and Production team. This position will be focused on the support of clinical production in a cGMP facility, as well as, support of equipment design, scale-up, specifications, installations, commissioning, and qualification.

Essential Functions:

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Lead the design, implementation and sustainability of manufacturing processes from feasibility through scale-up and commercial manufacturing
  • Ensure robust systems using accepted GMP design controls
  • Working with cross-functional teams to determine system requirements and specifications
  • Evaluate incoming processes for operability and develop risk assessment plans
  • Process development, scale-up, technology transfer and equipment/process validation activities
  • Author, review, and approve all SOPs and technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement
  • Understand practical statistics and identification of critical process parameters
  • Demonstrate ability to execute complex tasks and experiments independently
  • Maintain compliance with applicable cGMP regulations, vendor guidelines, engineering
    principles, and documentation

Minimum Education, Experience and Skills: 

  • Bachelor’s Degree in an engineering discipline or equivalent with 5 years of process
    experience in the biotech or pharmaceutical industry
  • Excellent written and interpersonal skills
  • Strong data analysis, troubleshooting and problem-solving skills
  • Strong understanding of equipment qualification, validation, scale up and tech transfer
  • Manage relevant engineering activities and prioritize work to ensure site and project timelines are met
  • Demonstrate knowledge in practice of researching engineering and design issues, as well as evaluating alternatives
  • Knowledge of engineering principles, standards, techniques, policies, and processes.
  • Experience with Facility Design/Expansion
  • Knowledge of cGMPs and experience working in a GMP biotechnology or pharmaceutical manufacturing setting
  • Detailed knowledge of facilities, systems, and infrastructure within a regulated industry setting


  • Upstream and downstream bioprocessing knowledge
  • Fill/finish knowledge
  • Experience in the biotech or pharmaceutical industries
  • Experience in Design of Experiments (DOE) and use of statistical analysis software (JMP)
  • Working knowledge of design (Solidworks) and fabrication of parts and assemblies
  • Ability to read and understand drawings, schematics, tolerances, and limits
  • Understanding of 21 CFR parts 11, 210 and 211 a plus
  • Working within a controlled production environment

Working with potentially infectious materials