10 Nov, 2021

Process Engineer

  • Merck
  • Carlsbad, CA, USA
Process Engineer Biochemicals / Pharmaceuticals Chemicals

Job Description

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

 

 

 

Your Role:

 

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

RSRMS

 

 

 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 


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