Sr. Validation Engineer

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 Sr. Validation Engineer will be responsible for supporting new and ongoing validation activities associated with Bionova Scientific’s cGMP Manufacturing Facility in accordance with current regulatory and industry standards. As part of the Q Validation group, you will take a hands-on approach to performing the qualification of equipment, utility systems, facilities, processes and/or automation systems and include tasks such as preparing protocols, analyzing test results, and preparing summary reports. As required, this person may also investigate and troubleshoot problems and propose solutions.

Essential Duties and Responsibilities:

• 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 validation studies
• Ensuring proper execution and GMP documentation according to cGMP and GDP.
• Adheres to established regulations and follows cGMP 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)
• Understanding of GMP documentation and technical writing abilities
• As required, in regulatory submissions and represents validation during inspections from regulatory agencies and client audits
  
  

Qualifications:

This individual should have a general understanding and application of validation principles, concepts, practices, regulations and standards. They should also be familiar in current Good Manufacturing Practices (cGMPs). 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
• 4 years of direct validation experience and 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, facility/warehouse, and QC instruments (e.g., HPLC, UPLCs)
• In-depth understanding of current GMP Standards, 21 CFR Part 11, Annex 1/11
• 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
• Familiar with Ellab dataloggers a plus
• Strong analytical and problem solving skills
• Flexibility with work hours to meet business needs
  
  

Compensation Range: The base compensation range for this role is between $85, 000 and $110,000. 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.