15 Feb, 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 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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:


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.

  • 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
  • Ability to influence cross-functional team members in the face of competing priorities
  • Participates in RCA activities for production failures and interfaces with peers in their troubleshooting efforts


The Employee will be required at times to lift up to 50 pounds and will conduct off- shift, weekend, and overtime duties as assigned by the manager of the employee.


Who you are:
Basics Qualifications:

  • Bachelor of Science degree in an Engineering or a Scientific discipline
  • 3+ years of experience with adherent or suspension mammalian cell culture, centrifugation, clarification, TFF (tangential flow filtration), chromatography, sterile filtration, and fill/finish operations.
  • 3+ years of experience in a cGMP biotech industry
  • 3+ years of experience generating, documenting, and implementing change controls with thorough justification and impact assessments

Preferred Qualifications:

  • Experience operating in a cGMP commercial manufacturing environment
  • Experience operating in a gowned clean room environment
  • Experience with mass balance, process flow diagrams, and P&ID’s
  • Experience with controls systems (PLC, DCS, Loop controllers)
  • Project Management and coordination experience associated with the execution of capital projects in an industrial environment



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!


Curious? Apply and find more information at https://jobs.vibrantm.com

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.

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