Engineer / Sr. Engineer

Bionova Scientific Process & Facilities Engineer / Sr. Engineer

Bionova Scientific is a rapidly growing, biologics and plasmid DNA manufacturing 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 Scientific is seeking a motivated, hands-on, and technically skilled Process & Facilities Engineer / Sr. Engineer to join our growing Facilities & Engineering (F&E) team. As part of the F&E group, you will support facility operations across GMP manufacturing, Development and Quality control laboratories, and utility systems and play a critical role in capital expansion, qualification, validation, and EHS program implementation.

This role provides a unique opportunity to gain broad exposure to Advanced Therapies operations, including engineering design, equipment qualification, clean utility management, and cross-functional collaboration to enable successful GMP execution and facility growth, that ultimately improve patient outcomes.

Essential Duties and Responsibilities :

GMP Manufacturing Facility Support

• Perform, manage or oversee preventive and corrective maintenance on GMP-critical utilities : HVAC, compressed gases, cryogenics, cleanroom systems, etc.
• Lead or support equipment validation efforts, including protocol generation, execution, and final report compilation.
• Monitor and maintain environmental conditions (temperature, RH, pressure) via BMS / EMS systems to ensure GMP compliance and audit readiness.
• Monitor critical parameters (e.g., temp, RH, DP) using BMS / EMS systems; respond to deviations and maintain control environments per Annex 1 and FDA expectations.
• Maintain and improve calibration and PM programs, using CMMS to track assets, work orders, and compliance records.
• Own or support commissioning, qualification (IQ / OQ / PQ), and validation for process equipment (FAT / SAT).
• Own or support commissioning, qualification (IQ / OQ / PQ), and validation for clean utilities (e.g., WFI, RO / DI, HVAC, BSCs, autoclaves) in accordance with GMP and validation protocols.
• Ensure adherence to cGMP and GDP standards across all documentation and facility operations.
• Act as SME or system owner for designated utilities or equipment. Support audits, deviations, CAPAs, and change controls.

Facilities Operations and Infrastructure

Project Engineering and Strategic Initiatives

EHS Support & Compliance

Expected Qualities :

Working Conditions :

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.