Principal Bioprocess Engineer - AgraForm Biologicals, LLC. - St. Louis, MO

About the role

AgraForm LLC is one of the leading agrochemical contract manufacturing companies in the U.S. and is centrally located in St. Louis, MO. We provide high-quality bulk formulation, agri-chemical processing, spray drying, milling, packaging, and storage services for chemical manufacturers. We utilize state-of-the-art equipment at our facility and are known for our attention to quality and service.

The Principal Bioprocess Engineer provides technical leadership for the design, start-up, scale-up, and optimization of processes within the AgraForm Biologicals Facility. This role is responsible for process engineering support across core biological manufacturing operations, including participation in capital project execution, commissioning, and sustained manufacturing support. The position serves as a subject matter expert for bioprocess systems while driving safe, reliable, and efficient operations in collaboration with cross-functional teams.

Responsibilities

• Lead equipment qualification (IQ/OQ/PQ) for all fermentation and downstream processing equipment within the facility.
• Design, optimize, and scale-up fermentation processes from bench/pilot scale to full commercial production across bioreactor platforms (stirred-tank, airlift, fed-batch, continuous).
• Establish and maintain critical process parameters (CPPs) and critical quality attributes (CQAs) for each microbial product line.
• Lead root-cause analysis and CAPA implementation for process deviations, contamination events, or yield excursions.
• Lead process risk assessments, including HAZOPs, PHAs, and biosafety reviews, and ensure process designs comply with EHS and regulatory requirements.
• Author and maintain master batch records (MBRs), standard operating procedures (SOPs), validation protocols, and regulatory submission dossiers.
• Act as the technical subject matter expert (SME) for biological manufacturing processes, supporting routine operations, troubleshooting, and deviation resolution.
• Serve as the primary point of contact for bioreactor OEMs, instrument vendors, and CIP/SIP system integrators.
• Develop and maintain process mass balances, design-of-experiment (DoE) plans, and technology transfer packages.
• Develop, review, and approve process engineering deliverables such as process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), mass and energy balances, equipment specifications, control philosophies, and process descriptions.
• Maintain sterility assurance programs including environmental monitoring (EM), clean room classifications, and cleaning validation.
• Develop preventive maintenance schedules; collaborate with engineering/maintenance teams on capital improvement projects.
• Support process scale-up and technology transfer activities from R&D, pilot-scale operations, or external manufacturing into commercial production.
• Monitor and analyze process performance data to ensure consistent operation within defined control limits and identify opportunities for improvements in safety, quality, yield, throughput, and cost.
• Define packaging specifications and cold chain / ambient requirements in coordination with supply chain.
• Identify and implement continuous improvement initiatives related to process reliability, capacity expansion, debottlenecking, and sustainability.
• Evaluate new technologies, equipment, and manufacturing strategies to enhance facility capability and long-term performance.
• Support preparation of technical documentation, reports, and presentations for internal stakeholders and leadership.
• Follows GROWMARK’s Code of Conduct and Corporate Compliance Program, Environmental Health and Safety, OSHA and DOT policies and procedures