Engineer/Sr. Engineer in Manufacturing Science and Technology (MSAT)

Asahi Kasei•Fremont, CA

3d•$122,000 - $155,000•Onsite

About The Position

The Engineer/Sr. Engineer, in Manufacturing Science and Technology (MSAT) will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific West Warren Fremont location. As part of the MSAT group, you will have opportunities to work on and specialize in expertise of Upstream (US) Cell Culture and/or Downstream (DS) Purification. The position will work with multiple functional teams at Bionova to coordinate GMP Manufacturing readiness activities, tech transfer, and support successful completion of client manufacturing projects.

Requirements

BS, MS, or PhD in Engineering, Life Sciences, or related discipline with 3-5 years (Engineer 1) and 5-10 years (Sr. Engineer) of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
Hands-on experience working in a GMP manufacturing facility with either upstream fermentation equipment (e.g. single-use bioreactor) or downstream purification equipment (e.g. chromatography).
Experience with process development, process characterization and/or tech. transfer processes.
Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
Experience with process monitoring software and equipment software (e.g. UNICORN, Pi Historian).
Experience with ERP systems (QAD is a plus).
Creative thinker that can identify better and more efficient methods to address issues and gaps.
Demonstrate ability to work independently, organize, and communicate effectively.
Ability to prioritize assignments and to manage multiple projects simultaneously.

Nice To Haves

QAD experience is a plus.

Responsibilities

Coordination or management of GMP manufacturing readiness and tech transfer tasks as part of new product introduction (NPI) for client projects.
Generate and maintain GMP material bill of materials (BOM) using ERP system (e.g. QAD).
Ensure facility fit and tech transfer process working with internal process development teams, vendors, and clients.
Support tech transfer of processes using single-use equipment including but not limited to: bioreactor, chromatography, depth filtration, Viral Filtration and/or TFF.
Support US or DS equipment troubleshooting, authoring deviations, corrective actions (CAPA), and change controls.
Author and review technical documents such as reports, experimental plans, production batch records, training materials, and manufacturing SOPs per project needs.
Assess process performance through analysis of key performance indicators.
Lead internal meetings and communicate effectively with internal stakeholders.
Contributes to quality activities such as investigations, authoring deviations, CAPAs, and Change Controls.
Undertake and successfully execute additional projects and assignments to refine and improve workstreams and systems.
Maintains own training within compliance and trains other upon completion of trainer qualification.
Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site.