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

Asahi-Kase; Fremont (CA); On-site; USD 122,000 - 155,000; Full time

Benefits offered by this job

Medical insurance

Dental

Vision

401K

Paid time off

Annual bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA is seeking an Engineer/Sr. Engineer in Manufacturing Science and Technology (MSAT).

You will contribute to manufacturing and technology transfer projects, specializing in Upstream Cell Culture and Downstream Purification, and coordinate readiness activities across GMP operations. The role requires hands-on GMP experience with single-use bioreactors or purification equipment; strong collaboration with cross-functional teams; and documentation of deviations,

Qualifications

• BS/MS/PhD in Engineering or Life Sciences.
• 3–5 years (Engineer 1) and 5–10 years (Sr. Engineer) of relevant experience in biopharma manufacturing.
• Hands-on GMP manufacturing experience with upstream or downstream equipment.
• Experience with process development, characterization and tech transfer.
• Familiarity with ERP and process monitoring software (QAD, Unicorn, Pi Historian).

Responsibilities

• Coordinate GMP manufacturing readiness and tech transfer tasks for new product introductions.
• Ensure readiness of raw materials, documents, equipment and facilities.
• Generate and maintain GMP BOM; use ERP system (QAD).
• Support tech transfer with single-use equipment (bioreactor, chromatography, depth filtration, viral filtration, TFF).
• Author deviations, CAPAs and change controls; document manufacturing activities.
• Lead internal meetings and communicate with stakeholders; train teammates as needed.
• Document work according to cGMP and cGDP; adhere to site regulations.

Skills

GMP manufacturing

Tech transfer

Process development

cGMP compliance

Project coordination

Education

Bachelor's degree

Master's degree

PhD in Engineering or Life Sciences

Tools

UNICORN

Pi Historian

QAD

Job description

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 LLCJob Description: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.Location: Fremont, CABenefitsDirect HireMedical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%)Paid time offAnnual Bonus eligibleEssential 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, 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.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.QualificationsBS, 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.The base compensation range for this role is $122,000-$155,000. 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.#LI-MG1As 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.