Company Summary:
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.
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
- 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.
- Coordinate 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.
Working Conditions:
- Role will involve working across GMP cleanrooms, mechanical spaces, laboratories, and general office areas.
- May require off-hours support or weekend availability during project execution or shutdowns
- 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, Facilities, or related technical field (or equivalent experience).
- Minimum 5 years of experience in facilities engineering, maintenance, or operations in a GMP-regulated environment.
- 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.
