Principal Engineer
Bionova Scientific LLC

Job Info

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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:

Bionova is seeking a motivated and innovative Principal Engineer to serve in the Facilities and Engineering department. As part of the F&E group, you will have opportunities to work on and take ownership of a wide range of projects from system and workflow implementation to facility and laboratory capital buildouts, troubleshooting and investigations, maintenance and calibration program management, Quality systems management, and overall lifecycle management in a GMP environment. Bionova is currently expanding its capabilities from a CDO to a CDMO through construction of a GMP manufacturing facility and QC testing laboratory. 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:

• Leads cross functional teams assembled for asset lifecycle management and quality system projects.
• Trains and coaches other F&E staff and cross functional colleagues utilizing deep and broad knowledge of industry and GMP operations.
• Responsible for specifying requirements necessary for safe, compliant and maintainable systems on which commissioning and qualification is based (e.g. user requirements specifications)
• Assist in GMP compliant detailed design for facility under quality change management and for construction satisfying design intent
• Facilitate and own as required the design and implementation of, and controls for, facilities equipment
• Creation of protocols for and oversight of Commissioning, SAT, FAT for utility and process systems
• 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
• Act as primary point of contact between company and construction contractors + A/E firm(s) for process scope. Field RFIs, submittals, and other official communications between construction stakeholders.
• Main technical interface with Validation Manager (VM) when VM is creating and executing qualifications
• Supports RFP activities for design and construction phases of projects
• Support establishing of procedures and processes for operation of facilities and interfaces with utilities and automation systems (BMS, EMS, Historian, CMMS, etc.)
• Executes asset management and acts as system owner, defines preventive maintenance and calibration for new assets
• System owner for specific facilities and utilities equipment
• 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.
• Primary F&E technical compliance liaison with auditors and inspectors to demonstrate safe, compliant operation and maintenance of facility, utility and equipment systems

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:

• At least 20 years experience performing duties of Process, Utilities, or Facilities Engineer with at least 10 years in a GMP manufacturing environment.
• Bachelor's of Science degree in engineering or related science discipline, Master's preferred
• Excellent English verbal and written communication skills
• Experience using CMMS systems, and owning quality system records in cGMP facilities
• Experience managing facility systems and being system owner in cGMP environment
• Experience interacting with regulatory agencies to defend Quality Systems
• Comfortable in a fast-paced, collaborative small-company environment, working with minimal direction and able to adjust workload based upon changing priorities.

Compensation Range: The base compensation range for this role is between $175,000 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.

This job has expired.