Sr. Instrumentation Lead

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 actively seeking a highly motivated Facility & Engineering Sr. Instrumentation Lead to join our dynamic Facilities and Engineering team. This individual will play a critical role in supporting the operation, maintenance, calibration, and compliance of facility systems and process instrumentation within a GMP-regulated environment. The role requires demonstrated proficiency with CMMS systems & administration, equipment reliability, and quality documentation in support of clinical and commercial manufacturing.  The ideal candidate will blend technical knowledge of building and lab systems with a disciplined approach to quality compliance, vendor coordination, and continuous improvement.

Essential Duties and Responsibilities:

• Lead facilities and instrumentation improvement projects including new asset CapEx projects with installation, qualification and quality document generation (ex. change control) and project resource management (matrixed, external and financial resources).
• Monitor, maintain, and troubleshoot critical utilities and building systems, including HVAC, electrical, plumbing, gases, fire protection, and general facility infrastructure.
• Perform and support basic repairs, preventive maintenance, and inspections to ensure uninterrupted operation of lab and manufacturing spaces.
• Perform and/or coordinate calibration of GMP and non-GMP instrumentation, including but not limited to the following parameters: temperature, pressure, humidity, flow, level, mass, pH, and conductivity devices.

• Troubleshoot, clean, and maintain process instrumentation to ensure performance accuracy.
• Own and manage instrument-related quality documentation, investigations, and data analysis in accordance with GMP requirements.
• Perform administration of the Computerized Maintenance Management System (CMMS) - Blue Mountain RAM.

• Schedule, assign, and document all maintenance and calibration related tasks in CMMS, ensuring timely completion and audit readiness.
• Coordinate with external vendors for maintenance, calibration, and repairs beyond internal capabilities.

• Manage vendor onboarding, scope definition, scheduling, PO/invoice processing, and performance monitoring.
• Complete and review GMP-compliant records including work orders, calibration reverse traceability reports, deviations, root cause analysis, change controls, SOPs, observations and CAPAs.

• Participate in regulatory and partner audits and inspections; present maintenance/calibration systems and provide supporting documentation.
• Work closely with Manufacturing, QA, Lab Operations, and Engineering teams to meet business needs and equipment readiness timelines.

• Responsible for ensuring ongoing management of environmental monitoring systems, lab gas systems, equipment contracts, and facility service requests.
• Lead the development, creation and management of maintenance spare parts lists and inventory systems.

• Interpret and work from technical drawings including P&IDs, wiring diagrams, and schematics.  Redline and communicate gaps as necessary.
• Maintain safe working conditions by following OSHA and internal safety procedures and wearing appropriate PPE.
• Participate and lead after-hours support, site shutdowns, and emergency maintenance as required.
• Other duties and responsibilities as assigned.

Working Conditions:

This position is required to work in a GMP manufacturing facility, development laboratories, and office environment. The role requires walking, standing, stooping, kneeling, crouching, and climbing of ladders. The employee must occasionally lift and or move up to 40 pounds independently.

Qualifications:

• Bachelor’s of Science degree in Scientific, Technical, Engineering or or related discipline, or equivalent experience.
• 15 years of experience in supporting facility operations within the biopharmaceutical or pharmaceutical industry.
• Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance requirements.
• Proficient in using building automation systems and facility management software.
• Experience with following Standard Operating Procedures, reading equipment drawings (i.e., P&IDs, wiring diagrams) and specifications.
• Experience with Maintenance / Calibration execution and scheduling and Computerized Maintenance Management Systems (CMMS)
• Experience using basic office software (Microsoft Office etc.) and writing technical documents.
• Experience interacting with regulatory agencies to defend Quality Systems preferred
• Experience with AI technology use.

As part of this role, there may be an opportunity to manage a team of direct reports in the near future. The ideal candidate should possess strong leadership skills and be capable of managing a small team effectively.

Excellent problem-solving and troubleshooting skills.

Strong communication and teamwork abilities.

Compensation Range: The base compensation range for this role is between $130,000 and $150,000. 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.