Engineer​/Sr. Engineer - Validation

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.

Bionova Scientific LLC

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. Responsibilities include preparing and executing protocols, analyzing test results, and preparing summary reports. The role may also involve investigating and troubleshooting discrepancies, proposing solutions, and managing CAPAs and change control.

As part of the F&E team, the engineer will drive cross‑functional decisions and influence user‑team decisions to expand capabilities and meet project goals that ultimately improve patient outcomes.

• Oversight of commissioning, SAT, FAT for utility and process systems
• Creation of protocols and oversight of commissioning, SAT, FAT for systems
• Creation and execution of 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
• Adhere to established regulations and follow cGxP established by site
• Assist in writing and revising documentation, including SOP, URS, SIA, VMP, VPP, etc.
• Understand GxP documentation and possess technical writing abilities
• Represent qualification during inspections from regulatory agencies and client audits
• Sustain process equipment after construction as needed
• Execute continuous improvement or NPI changes to process equipment under QA oversight (GMP compliance)
• Follow GxP principles in troubleshooting equipment issues and ensure equipment satisfies user (operations) requirements
• Operate 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 facilities under quality change management and for construction satisfying design intent
• Sustain systems after construction and execute changes under QA oversight (GMP compliance)
• Perform other activities and duties as required or assigned

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.

• 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…