05 Jan, 2022

Process Engineer

  • Merck
  • Carlsbad, CA, USA
Process Engineer Chemicals

Job Description

The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. Our Process Engineer’s primary responsibility is to support ongoing operations at the Carlsbad, CA site through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Responsibilities of the Process Engineering function include both tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business. The role reports into the Manufacturing department at the site.  The engineer is responsible to support the development of scope, design, client interface, cost and schedule development, project reporting, construction oversight, construction safety, procurement, start-up scheduling and execution, and managing validation interfaces on assigned capital projects. Acts as Subject Matter Expert in a specific technical area with responsibilities to train and support users, troubleshoot and resolve operational problems, and process improvement projects. This position takes supervisory direction but sets their day-to-day activities.


  • Drives change control records with thorough documentation, justification, and impact assessments
  • Supports new production equipment including - URS generation, equipment selection, management, capital expense process, FAT/SAT execution, pFMEA and risk assessment documentation, commissioning, and SOP development
  • Supports existing production equipment repairs, replacement, transfer, and coordination
  • Assists team with identifying solutions to production challenges
  • Sources materials and resources internally/externally as needed for various projects independently
  • Demonstrates technical problem-solving skills related to complex project execution and site equipment/systems troubleshooting challenges
  • Participates in RCA activities for production failures and interfaces with peers in their troubleshooting efforts
  • Reads literature and guidance documents directly associated with assigned project and related areas


Who you are:


Minimum Qualifications:

  • Bachelor of Science degree in Biology or Engineering discipline
  • 4 + years of experience in a production environment working on complex / automated equipment such as Bioreactors, Purification skids, Fill finish, autoclaves, welders etc.


Preferred Qualifications:

  • In-depth working knowledge of cGMP requirements
  • Experience with adherent or suspension mammalian cell culture, centrifugation, clarification, TFF (tangential flow filtration), chromatography, and sterile filtration
  • Experience in biotech industry
  • Experience in support of design and operation of Biopharmaceutical facilities for manufacturing and support systems
  • Experience generating justifications and impact assessments and implementing change controls
  • Project Management and coordination experience associated with the execution of capital projects
  • Experience with control systems (PLC, DCS, Loop controllers)
  • Creation and review of Process Flow Diagrams and Piping and Instrument Diagrams
  • Experience with URS, Conceptual Design and FAT / SAT support





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