MSAT Engineer/ Senior Engineer - Temporary/ Full-time

CIS Materials; Fremont (CA); On-site; USD 62,000 - 90,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA seeks an MSAT Engineer/Sr. Engineer to advance GMP manufacturing readiness and technology transfer for biopharma projects. The role emphasizes collaboration across functional teams and effective documentation within cGMP frameworks.

Required are 3–5 years (Engineer 1) or 5–10 years (Sr. Engineer) in GMP biopharma, with experience in upstream/downstream equipment, tech transfer, and ERP systems like QAD. On-site position with competitive compensation.

Qualifications

• 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 in a GMP manufacturing facility with 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).
• 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.

Responsibilities

• Coordinate GMP manufacturing readiness and tech transfer tasks as part of new product introduction (NPI) for client projects.
• Generate and maintain GMP material BOM; use ERP systems (QAD).
• Ensure facility fit and tech transfer with internal process development teams, vendors, and clients.
• Support tech transfer of processes using single-use equipment (bioreactor, chromatography, depth filtration, VD and/or TFF).
• Support US or DS equipment troubleshooting, deviations, CAPAs, and change controls.
• Author/review technical documents: reports, plans, batch records, training materials, SOPs.
• Lead internal meetings and communicate with stakeholders.
• Contribute to investigations, deviations, CAPAs, and Change Controls.
• Maintain training and train others; document work per cGMP/cGDP.

Skills

GMP manufacturing

Upstream fermentation

Downstream purification

Tech transfer

Process development

cGMP compliance

Cross-functional communication

Project management

Education

Bachelor/Master/PhD in Engineering or Life Sciences

Tools

UNICORN

Pi Historian

QAD

Job description

MSAT Engineer/ Senior Engineer - Temporary/ Full-timeWe use cookies to make the safest and most effective website possible.# Career Opportunities## MSAT Engineer/ Senior Engineer - Temporary/ Full-timeApply: On-site: Fremont, CA: Full time: Posted Today: R5900## The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.**Company:**Bionova Scientific LLC**Job Description:**The Engineer I/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. Job location will be in Fremont, California. **Essential Duties and Responsibilities** • Based on experience, coordination or management of GMP manufacturing readiness and tech transfer tasks as part of new product introduction (NPI) for client projects. Candidate will work with Bionova functional teams to ensure readiness of raw materials, documents, equipment, processes and facilities activities.• Generate and maintain GMP material bill of materials (BOM). Activities will involve 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, VD 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.• 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. **Working Conditions** This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently. **Qualifications** • 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).• 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. The base compensation range for this role is $45 - $65/ hour. Base compensation is influenced by many factors including, but not limited to time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity and business/ economic conditions. *As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.*