Validation Engineer

1 week ago

Fremont, United States Asahi Kasei Full time
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: The Validation Engineer will be responsible for supporting new and ongoing qualification activities associated with Bionova Scientific’s new cGMP Manufacturing Facility in accordance with current regulatory and industry standards. The Validation Engineer will take a hands-on approach to performing the qualification of systems (facilities, utilities, equipment), 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 and propose solutions. 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:

  • Oversight of Commissioning, SAT, FAT for utility and process systems
  • Authoring, reviewing, approving, and executing development and/or validation 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.
  • 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: This individual should have a general understanding and application of qualification principles, concepts, practices, regulations and standards. They should also be familiar in current Good Manufacturing Practices (cGMPs). He/She must have working knowledge of facility, manufacturing and laboratory equipment and systems, as well as some knowledge of industry practices. Additionally, an excellent verbal, written and interpersonal communication skills are highly desired.

  • Bachelor’s degree in a science related or engineering background preferred
  • 2+ years of direct qualification experience and/or working in a cGMP manufacturing environment
  • 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
  • Experience with MasterControl a plus

Compensation Range: The base compensation range for this role is between $85,000 and $100,000. 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.

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