Facility and Validation Engineer

About the role

Bionova Scientific LLC is a subsidiary of Asahi Kasei Medical, a division of the Asahi Kasei Group. 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. The company looks for candidates with a strong desire to serve and adaptability to solve complex client problems.

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.
  • 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:
  • Oversee maintenance of site infrastructure electrical, plumbing, fire safety, lighting, structural, and automation systems.
  • Monitor Building Management Systems (BMS), respond to alarms, and support utilities integration.
  • Cookordinate and supervise contractor/vendor activities ensuring adherence to GMP, EHS, and internal SOPs.
  • Manage small facility projects (e.g., room upgrades, equipment installations, relocations).
  • Ensure spare parts, tools, and critical consumables are tracked and available to minimize client and internal programs downtime.
• Project Engineering and Strategic Initiatives:
  • Participate in facility expansions, renovations, or lab buildouts; provide specifications and design input.
  • Interface with architects, engineers (A&E), and construction teams to provide input on design specifications and user requirements.
  • Lead or assist in implementation of automation, asset management systems (CMMS, Historian), and clean utility projects.
  • Support equipment selection, procurement, FAT/SAT, and onboarding to operational readiness.
  • Drive operational excellence through data-driven analysis, process optimization, and cross-functional engagement.
• EHS Support & Compliance:
  • Support implementation and enforcement of Environmental, Health, and Safety (EHS) protocols in labs, GMP suites, mechanical spaces, and contractor-managed areas.
  • Conduct or assist in EHS risk assessments, inspections, and incident follow-up activities.
  • Ensure all facility work is conducted safely, using LOTO procedures, PPE, and applicable permit systems.

Qualifications

• Bachelor’s degree in engineering, Facilities, or related technical field (or equivalent experience).
• Solid knowledge of facility systems: HVAC, BMS, EMS, cleanrooms, electrical, plumbing, and water systems.
• Experience with equipment qualification (IQ/OQ/PQ) and validation of process/lab equipment under cGMP.
• Experience with CMMS and GMP documentation systems.
• Familiarity with FDA, EU Annex 1, ISPE Baseline Guides, and industry EHS best practices.
• Excellent troubleshooting, problem-solving, and technical communication skills.
• Demonstrated ability to manage vendors, projects, and maintenance programs.
• Able to lift up to 50 lbs and work in varied environments (mechanical rooms, rooftops, cleanrooms).
• Strong organizational skills and ability to multitask across priorities in a fast-paced setting.
• Able to work in mechanical rooms, cleanrooms, and elevated spaces; capable of lifting up to 50 lbs as needed.

Pay

The base compensation range for this role is $87,000-$97,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.