Process Engineer/Senior Process Engineer

Process Engineer/Senior Process Engineer

Process Engineer/Senior Process Engineer

FUJIFILM Diosynth Biotechnologies Thousand Oaks, CA

The Process Engineer/Senior 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/Senior 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.

• Seniority level

  Mid-Senior level

• Employment type

  Full-time

• Job function

  Manufacturing and Engineering

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at FUJIFILM Diosynth Biotechnologies by 2x

Featured Benefits

Inferred from the description for this job

Senior Process Engineer in Thousand Oaks, CA

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