Process Engineer

Location
San Diego, CA, US
Posted
Sep 20, 2020
Ref
662768200
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Position Summary

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 3-5 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


Preferred:
  • 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


Physical/Mental Demands and Work Environment Characteristics

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job. The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.