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

GROWMARK, Inc.; Oakville (MO); On-site; USD 140,000 - 160,000; Full time

Job summary

AgraForm LLC in St. Louis, MO seeks a Principal Bioprocess Engineer to lead design, start-up, scale-up, and optimization of bioprocesses across fermentation and downstream operations.

You will serve as SME for bioprocess systems, support capital projects, and ensure safe, reliable manufacturing with strong collaboration across cross-functional teams. A strong background in regulated biotech environments is required.

Qualifications

• Bachelor's degree in chemical/biochemical engineering required.
• 7+ years progressive experience in bioprocess or biological manufacturing.
• Experience supporting capital projects, facility start-ups or major process changes.
• Strong understanding of scale-up, process design and process control.
• Experience in regulated manufacturing and problem solving.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Lead IQ/OQ/PQ for fermentation and downstream equipment.
• Design and scale-up fermentation processes to commercial production.
• Maintain CPPs and CQAs for microbial product lines.
• Lead root-cause analysis and CAPA for deviations and yield issues.
• Lead process risk assessments (HAZOPs, PHAs) and biosafety reviews.
• Author and maintain MBRs, SOPs, validation protocols, regulatory dossiers.
• Serve as SME for biological manufacturing processes and support operations.
• Interface with bioreactor OEMs, instrument vendors, and CIP/SIP integrators.
• Develop DoE plans and technology transfer packages.
• Produce PFDs, P&IDs, mass/energy balances, equipment specs, control philosophies.
• Maintain sterility programs and environmental monitoring.

Skills

Bioprocess engineering

Scale-up

CPPs/CQAs

CAPA

DoE planning

Education

Bachelor's in Chemical Engineering

Master's or PhD preferred

Job description

SALARY RANGE: $140,000 - $160,000

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.

PURPOSE AND SUMMARY STATEMENT

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.

ESSENTIAL JOB FUNCTIONS

• 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.

OTHER JOB FUNCTIONS

• 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, as they apply.
• Performs all other duties as assigned.

REQUIREMENTS

Normally requires a bachelor's degree in chemical engineering, Biochemical Engineering, Biotechnology, or a related engineering discipline; Master's degree or PhD is preferred, and seven or more years of progressive experience in bioprocess engineering, process engineering, or biological manufacturing environments.

Experience supporting capital projects, facility start-ups, or major process changes in an industrial manufacturing setting.

Strong understanding of process engineering fundamentals, including scale-up, process design and process control.

Demonstrated ability to troubleshoot process and equipment performance issues in a production environment.

Experience working in regulated, quality-driven, or safety-critical manufacturing operations.

Strong analytical, problem-solving, and organizational skills, with the ability to manage multiple priorities.

Effective written and verbal communication skills and the ability to collaborate across cross-functional teams.

Ability to work in an industrial manufacturing environment and perform field-based engineering activities.

Demonstrates essential abilities including business knowledge, collaboration, communication, customer focus, decision making and skill development.

Must have and maintain a valid driver's license and satisfactory driving record.

Must be willing to work with biohazardous agents.

The performance of this position will present exposure to an industrial environment and requires support and compliance with the published Company PPE policy including but not limited to the use of personal protective equipment such as safety glasses with side shields, appropriate attire, safety shoes, hard hat, hearing protection, etc.

Frequently exposed to noisy conditions and working conditions that may include dust, fumes, chemicals and electrical hazards that require appropriate safety measures.

Ability and willingness to participate in required training that may include education on GROWMARK's policies and procedures and additional training as it relates to the requirements of the position.

We are an equal opportunity/Disabled/Protected Veteran Employer. All individuals, regardless of demographic or other background, are encouraged to apply. Further, as a federal, state, and local contractor, we comply with government regulations and executive orders as applicable, including affirmative action responsibilities for qualified individuals with disability and protected veterans.

Employment is contingent on, among other things, receipt of an acceptable and job-related background check, drug test, motor vehicle report, and/or reference check, as applicable and permissible by law.