Process Engineer

Posted 21 Jul 2022

Carlsbad, California - United States

Req Id 253298



A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 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.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.



Now offering a $5,000 Sign-on Bonus for those that qualify!

Your Role:

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 to 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 Domain Expert in a specific technical area with responsibilities to train and support users, solve and resolve operational problems, and process improvement projects.

This position takes supervisory direction but sets their day-to-day activities.

  • Inspires 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 collaborates with peers in their troubleshooting efforts
  • Reads literature and guidance documents directly associated with the assigned projects and related areas

Who You Are:

Minimum Qualifications:

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


Preferred Qualifications:

  • Project Management and coordination experience associated with the execution of capital projects
  • Experience with control systems (PLC, DCS, Loop controllers)
  • Experience with adherent or suspension mammalian cell culture, centrifugation, clarification, TFF (tangential flow filtration), chromatography, and sterile filtration
  • Experience in support of design and operation of Biopharmaceutical facilities for manufacturing and support systems
  • Creation and review of Process Flow Diagrams and Piping and Instrument Diagrams
  • Experience with URS, Conceptual Design, and FAT/SAT support fulfill


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at
If you would like to know more about what diversity, equity, and inclusion means to us, please visit

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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