Principal Engineer, Automation

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.

Job Summary

Bionova is seeking a highly motivated Principal Automation Engineer to join our Facilities and Engineering (F&E) team as we expand from a Contract Development Organization (CDO) to a Contract Development and Manufacturing Organization (CDMO). This role provides an opportunity to lead and take ownership of a wide range of projects related to facility automation, utilities integration, capital expansion, and lifecycle management within a regulated GMP environment.

The Principal Automation Engineer will play a critical role in integrating Building Management Systems (BMS), automation infrastructure, and utility controls to support the construction, commissioning, and ongoing operation of our new GMP manufacturing facility and QC laboratory. This position will also oversee system administration, data integration, troubleshooting, and continuous improvement of automation platforms to ensure compliance, efficiency, and operational excellence.

Essential Responsibilities:

• Serve as a IT/OT administrator for GMP systems including maintaining user accounts, performing administrative changes under change management, and ensuring state of compliance for GMP IT/OT computer systems.
• Serve as system owner for BMS, BAS, utilities, and automation platforms, including integration of BAS, EMS, and Historian systems across GMP operations.
• Lead the design, implementation, commissioning (FAT, SAT, IOQ, PQ), and qualification of automation systems, utilities, and facility equipment in alignment with user requirements, design intent, and regulatory standards.
• Collaborate with project teams, contractors, and A/E firms to drive automation scope, technical decisions, and successful project execution for facility buildouts and infrastructure upgrades.
• Spearhead alarm reduction initiatives by resolving excessive alarms across automation platforms, stabilizing operations, improving response times, and maintaining compliance with GMP, QA, and safety standards.  
• Specify technical requirements to ensure the design, construction, and commissioning of maintainable, compliant, and reliable automation systems.
• Lead system performance monitoring, alarm management, data integrity initiatives, and troubleshooting for automation infrastructure supporting critical GMP operations.
• Drive cross-platform data integration, consolidating performance data from automation, utilities, EMS, and historian systems to enable predictive maintenance, advanced troubleshooting, and continuous improvement.
• Lead AI integration projects to enhance data analytics, operational efficiency, and GMP-compliant decision-making.
• Develop SOPs, lifecycle documentation, change control records, and preventive maintenance programs for new and existing systems to support reliable operation and audit readiness.
• Own system lifecycle management, including technical specifications, SOP development, change control, commissioning, qualification, and preventive maintenance programs.
• Ensure alignment with GEP, cGMP, and regulatory standards throughout system upgrades and continuous improvement projects.
• Provide hands-on IT support for automation platforms, including user management, network troubleshooting, and system stability.
• Manage system backups, patching, and infrastructure maintenance to safeguard data integrity and reliable operation.
• Act as primary technical liaison with the qualification team to ensure proper qualification and system acceptance in compliance with GMP requirements.
• Lead design, implementation, commissioning (FAT, SAT, IQ/OQ/PQ), and qualification of utilities, automation, and process equipment.
• Sustain utilities and automation systems post-construction, overseeing continuous improvements, system modifications, and lifecycle changes under GMP quality oversight.
• Act as primary technical liaison with Validation, Quality, and Compliance teams to ensure successful qualifications and regulatory inspection readiness.
• Own quality system records as SME for automation, including deviations, CAPAs, audits, and change management activities.
• Mentor and train F&E staff and cross-functional colleagues in automation best practices, troubleshooting, and lifecycle management to support long-term system reliability and operational success.
• Support facility procedures and processes for safe, compliant operation, interfacing with utilities, BMS, EMS, CMMS, and data historian platforms.
• Serve as a technical point of contact with auditors and regulatory inspectors, demonstrating compliant operation and maintenance of automation and facility systems.

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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 degree in Engineering, Automation, or a related technical discipline; Master’s preferred.
• 15+ years of experience in automation, BMS/BAS systems, utilities, or process controls, with 10+ years supporting cGMP manufacturing facilities.
• Extensive experience as a system owner for BMS, BAS, or utilities infrastructure in a regulated, GMP environment.
• Proficient in automation system integration, controls development, alarm management, and data integrity initiatives.
• Hands-on experience with BAS, EMS, CMMS, and data historian platforms.
• Strong background in AI/data analytics, IT troubleshooting, alarm management, and system optimization.  
• Demonstrated ability to lead cross-functional teams through system design, commissioning, validation, and continuous improvement.
• Strong background in lifecycle management, change control, deviations, and regulatory inspections within a GMP facility.
• Excellent written and verbal communication skills, with the ability to mentor teams and effectively interface with technical and non-technical stakeholders.
• Comfortable working in a fast-paced, collaborative environment with evolving priorities and high accountability for system performance and compliance.

Compensation Range: The base compensation range for this role is between $165,000 and $185,000. 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.