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Process Engineer

Company: BioSpace, Inc.
Location: Thousand Oaks
Posted on: March 19, 2023

Job Description:

Job Details

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Process Engineer report directly to the Associate Director, Project Engineering at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will participate in tech transfers of new technologies into our GMP manufacturing operation. They will be responsible for taking the lead on small to mid-size capital projects.

External US

The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

The Process Engineer works as part of the Facilities, Engineering, & EHS team supporting Fujifilm Diosynth Biotechnologies California's (FDBC's) cGMP cell therapy production facility. This position will contribute to capital projects supporting the maintenance, modification, and expansion of the facility, as well as ongoing production operations delivering product to the clinic. The Process Engineer will provide process engineering support for technology transfer, process equipment evaluation, process validation, and GMP manufacturing.

Reports to: Associate Director, Project Engineering

Work Location: Thousand Oaks, CA

Travel: Up to 10%

Primary Responsibilities:

  • Evaluate process equipment specific to cell therapy production and make recommendations to management.
  • Participate in technology transfers of new technologies into GMP manufacturing operations.
  • Act as owner's representative and engineering lead on small to mid-size capital projects related to manufacturing expansion, process capability, and process improvement projects.
  • Manage budget and schedule for assigned projects. Position will be required to routinely give updates to management, both in writing and verbally.
  • Must have ability to understand manufacturing process and equipment related engineering tools such as process flow diagrams and/or engineering specifications/requirements documents.
  • Write documents pertaining to equipment procurement and operation.
  • Work with the quality group to support regulatory filings.
  • Support or own deviations, change controls, and CAPAs.
  • Provide on floor support for manufacturing and identify improvement opportunities.
  • Investigate problems, perform root cause analysis, and implement solutions.
  • Must have strong written and verbal communication skills and be a team player.
  • Previous experience in an engineering role supporting cell therapy production facilities is a plus.
  • Experience with computer and documentation systems is preferred.
  • Good decision making with strong judgment through collaboration and consideration of others point-of-view.
  • Flexibility to work on any shift required to accommodate the business needs.
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. Qualifications:
    • Bachelor's degree preferred in field of biochemical/chemical/mechanical/electrical engineering or life sciences.
    • 4+ years related work experience.
    • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process and/or computer system validation experience is a plus.
    • Must be knowledgeable and have worked in biotech manufacturing related industry.
    • Demonstrated understanding of cGMP principles.
    • Capital project experience is a plus.
    • Project management experience is a plus.
    • Role model for company core values of trust, delighting our customers, Gemba, and Genki. Salary and Benefits:
      • $95,000-$110,000 salary, depending on experience.
      • Medical, Dental, Vision
      • Life Insurance
      • 401k
      • Paid Time Off
        Join us! FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

        FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

        To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: BioSpace, Inc., Thousand Oaks , Process Engineer, Engineering , Thousand Oaks, California

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