Engineer/Sr. Engineer - Validation

Asahi Kasei•Fremont, CA

2d•Onsite

About The Position

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. Position Summary: Bionova is seeking a motivated and innovative Sr. Validation Engineer to serve in the Facilities and Engineering department. The Sr. Validation Engineer will take a hands-on approach to performing the commissioning and qualification of systems (facilities, utilities, equipment & analytical instruments), processes and/or automation systems and include tasks such as preparing and executing protocols, analyzing test results, and preparing summary reports. As required, this person may also investigate and troubleshoot discrepancies/deviations, propose solutions and manage CAPAs and change control. 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.

Requirements

5-10 years’ experience performing duties of Process, Utilities, or Facilities Engineer with at least 3-5 years in a GMP manufacturing environment.
Bachelor’s of Science degree in engineering or related science discipline
Excellent English verbal and written communication skills
Experience using CMMS systems in cGMP facilities
Strong technical knowledge of validation principles, Quality Systems, manufacturing, and facility equipment/systems
Experience with systems such for autoclaves, controlled temperature units, utilities (e.g., WFI, CDA, HVAC), single use bioreactors (SUB), mixers, warehouse, and/or QC instruments (e.g., HPLC, UPLCs)
Knowledge of current GMP Standards
Ability to work individually and in a team environment
Ability to multitask and prioritize tasks
Interact well and professionally with diverse group of individuals
Self-motivated and willing to be proactive in resolving issues
Flexibility with work hours to meet business needs, including weekends and holidays, as needed
Comfortable in a fast-paced, collaborative small-company environment, working with minimal direction and able to adjust workload based upon changing priorities.

Nice To Haves

Experience with MasterControl a plus

Responsibilities

Oversight of Commissioning, SAT, FAT for utility and process systems
Creation of protocols for and oversight of Commissioning, SAT, FAT for systems
Creation and execution for development and/or qualification protocols (IQ, OQ, PQ) and summary reports, including data analysis
Retrieve and compile data from electronic sources/databases and paper records
Participate in execution of development and/or qualification studies
Adheres to established regulations and follows cGxP established by site
Assist in writing and revising other documentation including: Standard Operating Procedures (SOP), User Requirements Specifications (URS), System Impact Assessments (SIA), Validation Master Plan (VMP), Validation Project Plans (VPP), etc…
Understanding of GxP documentation and technical writing abilities
As required, in regulatory submissions and represents qualification during inspections from regulatory agencies and client audits
As needed, 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
Operates within GMP quality systems as record owner or subject matter expert including deviations, change control, CAPA, audits and other quality systems.
Assist in GMP compliant detailed design for facility under quality change management and for construction satisfying design intent
Sustains systems after construction.
Executes (e.g. continuous improvement or NPI) changes to systems under QA oversight (GMP compliance)
Follows GxP principles in troubleshooting equipment issues and ensures equipment is satisfying user (operations) requirements
Other activities and duties as required or assigned.