Engineer - Facilities and Engineering at Bionova Scientific LLC in Fremont, California

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 LLC



Job Description:




Company Summary:



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.



Position Summary:



Bionova is seeking a motivated and innovative Process & Facilities Engineer to serve in the Facilities and Engineering department. As part of the F&E group, you will have opportunities to work on and take ownership of a wide range of projects from system and workflow implementation to facility and laboratory capital buildouts, troubleshooting and investigations, maintenance and calibration program management. Bionova is currently expanding its capabilities from a CDO to a CDMO through construction of a GMP manufacturing facility and QC testing laboratory. As part of the F&E team, you will drive cross-functional decisions and influence decisions of user teams as we grow the organization and expand capabilities to meet project goals that ultimately improve patient outcomes.



Essential Duties and Responsibilities:

• System owners for specific facilities and utilities equipment including monitoring and maintaining critical building systems, including Building management system, HVAC, plumbing, electrical, and fire protection.


• Troubleshoot and support repair of facility and process systems.


• Responsible for specifications for all facilities and equipment on which qualification is based (e.g. user requirements specifications)


• Assist in GMP compliant detailed design for facility under quality change management and for construction satisfying design intent


• Facilitate and own as required the design and implementation of and controls for facilities equipment


• Creation of protocols for and oversight of Commissioning, SAT, FAT for utility and process systems


• Sustains process equipment after construction. Executes (e.g. continuous improvement or NPI) changes to process equipment under QA oversight (GMP compliance)


• Follows GxP principles in troubleshooting equipment issues and ensures equipment is satisfying user (operations) requirements


• Act as point of contact between company and construction contractors + A/E firm(s) for process scope. Field RFIs, submittals, and other official communications between construction stakeholders.


• Technical interface with Validation Manager (VM) when VM is creating and executing qualifications


• Supports RFP activities for design and construction phases of projects


• Support establishing of procedures and processes for operation of facilities and interfaces with utilities and automation systems (BMS, EMS, Historian, CMMS, etc.)


• Executes asset management and acts as system owner, defines preventive maintenance and calibration for new assets


• Operates within GMP quality systems as record owner or subject matter expert including deviations, change control, CAPA, audits and other quality systems.


• Other activities and duties as required or assigned.

Working Conditions:



This position requires work in office, manufacturing, warehouse, and lab settings. The role requires walking, standing, stooping, kneeling, and crouching. The employee may occasionally lift and or move up to 40 pounds independently.



Qualifications:

• Bachelor's of Science degree in engineering or related science discipline


• Experience performing duties of Process, Utilities, or Facilities Engineer with experience in GMP manufacturing environment preferred.


• Excellent English verbal and written communication skills


• Comfortable in a fast-paced, collaborative small-company environment, working with minimal direction and able to adjust workload based upon changing priorities.

Compensation Range: The base compensation range for this role is between $70,000 and $85,000. However, the actual compensation may vary depending on your experience and qualifications.


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.


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. Apply Now