Asahi Kasei Bioprocess America, Inc. · 4 months ago
Bioprocess Engineer
Fremont, CA
Full-time
Onsite
Entry, Mid Level
$80K/yr - $90K/yr
2+ years expAsahi Kasei Bioprocess America, Inc. is part of the Asahi Kasei Group, dedicated to creating innovative solutions for tomorrow. They are seeking a Manufacturing Bioprocess Engineer – Downstream who will be responsible for executing downstream bioprocesses and ensuring the delivery of GMP-compliant drug substances through process troubleshooting and continuous improvement.
BiotechnologyManufacturing
Responsibilities
Act as SME for downstream operations (column packing, chromatography, UF/DF, filtration, pooling, and formulation)
Provide technical guidance and floor support for real-time issue resolution
Monitor process data and control parameters to ensure consistent product quality
Material management and coordination with Supply Chain
Investigate, manage, and own downstream-related deviations in the Quality Management System
Perform root cause analysis and implement effective CAPAs
Manage downstream-related change controls and ensure successful implementation
Develop and deliver training on chromatography, filtration, and purification workflows
Mentor operators on column packing techniques, skid operation, and GMP compliance
Ensure robust documentation of training activities
Support MSAT with technology transfer
Identify and implement process improvements to increase yield, robustness, and efficiency in downstream operations
Apply Lean/Six Sigma tools to optimize workflows and reduce variability
Author, revise, and review downstream SOPs, Electronic batch records, and work instructions
Ensure readiness for audits by maintaining GMP compliance across upstream operations
Qualification
Required
BA/BS in Biological Science, Biotechnology, or Biochemical Engineering with 4 years' experience in upstream pharmaceutical manufacturing; OR MS with 2 years' experience in GMP upstream operations
Hands-on experience with purification unit operations (chromatography, filtration, UF/DF)
Knowledge of process automation platforms (e.g., Unicorn, DeltaV)
Familiarity with biochemical principles underlying protein purification
Knowledge of process automation and single-use technologies
Familiarity with scientific principles driving biologics production
Strong deviation ownership, CAPA development, and technical writing skills
Ability to troubleshoot complex downstream issues and coach others effectively
Strong problem-solving and facilitation skills
Experience in training/mentoring operators in GMP downstream processes
Project management or Operational Excellence/Six Sigma background
Benefits
Health Benefits and Program: Bionova offers health benefits at a subsidized rate.
Healthcare, Dental, and Vision insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 days of Holidays and 5 days of Sick Leave.
Company
Asahi Kasei Bioprocess America, Inc.
As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust, by dependably supplying innovative yet exceptionally reliable bioprocess consumables, equipment and scientific support services.
51-200 employees
H1B Sponsorship
Asahi Kasei Bioprocess America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Daniel Strauss
Director of R&D
Recent News
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2025-02-25
2025-02-18
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