Process Specialist

Microbial-Discovery-Group-1; Franklin (WI); On-site; USD 75,000 - 110,000; Full time

Job summary

Microbial-Discovery-Group-1 is seeking a Process Specialist to support validation, optimization, and standardization of fermentation and manufacturing processes, collaborating with Engineering, Manufacturing and Quality to drive improvements in bioreactor operations and downstream processing.

The role emphasizes hands-on process support, data analysis, robust documentation, SOP development, and training of production personnel, with focus on continuous improvement, CAPA, and change control in a

Qualifications

• Bachelor's degree in engineering, biotechnology, biology, chemistry, or a related field.
• Two to five years of relevant manufacturing experience (biotech/fermentation/pharma).
• Experience in GMP-compliant or document-controlled settings.
• Strong data-driven troubleshooting and problem-solving ability.

Responsibilities

• Develop, review, and maintain SOPs, work instructions, and process documentation for fermentation and manufacturing operations.
• Monitor production processes and equipment performance to identify deviations and opportunities for improvement.
• Collect, review, and analyze process data to support troubleshooting and root cause analysis.
• Partner with Engineering, Manufacturing and Quality to evaluate and implement process improvements.
• Provide hands-on technical support to production personnel during operations and improvement initiatives.
• Train personnel on SOPs, changes, and standardized operating practices.
• Support validation activities, including protocols, reports, and equipment records.

Skills

Fermentation processes

Data analysis

Root cause analysis

Documentation discipline

Troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in engineering/biotech/biology/chemistry

Tools

Microsoft Excel

GMP systems

Process validation software

Job description

Position Summary

The Process Specialist supports the validation, optimization, standardization and continuous improvement of manufacturing processes and equipment within MDG's fermentation operations. This role works cross-functionally with Engineering, Manufacturing and Quality to improve upstream and downstream production processes, including bioreactor operations, centrifugation, freeze drying, spray drying and related production systems. Success in this role requires strong technical judgment, hands-on manufacturing support, data analysis, documentation discipline, troubleshooting ability and a continuous-improvement mindset. The Process Specialist provides technical support, process monitoring, root cause analysis, training and documentation updates to improve process performance, product quality, operational efficiency and manufacturing consistency.

Key Responsibilities

• Develop, review, revise and maintain SOPs, work instructions and process documentation for fermentation and manufacturing operations.
• Monitor production processes and equipment performance to identify deviations, recurring issues, inefficiencies and opportunities for improved consistency, reliability and throughput.
• Collect, review and analyze process data to support troubleshooting, root cause analysis, corrective actions and process optimization.
• Partner with Engineering, Manufacturing and Quality to evaluate and implement process improvements, including updates to procedures, operating parameters, equipment and manufacturing practices.
• Provide hands-on technical support to production personnel during routine operations, process changes, troubleshooting activities and improvement initiatives.
• Train production personnel on SOPs, work instructions, process changes and standardized operating practices.
• Support validation activities, including preparation and maintenance of validation protocols, reports, equipment records, process documentation, schematics, and engineering change notices.
• Maintain working knowledge of fermentation, centrifugation, freeze drying, spray drying and related manufacturing technologies.
• Support change control, deviation investigations, corrective and preventive actions and quality-system documentation as assigned.
• Stay informed of applicable industry practices, regulatory expectations and documentation requirements relevant to manufacturing processes.
• Identify and communicate practical process-improvement opportunities to leadership.
• Support cross-functional projects, equipment evaluations and production-readiness activities as assigned.
• Perform other responsibilities as needed to support departmental and company objectives.

Work Environment

• Work is performed in both temperature-controlled office areas and production-floor environments.
• The role requires hands-on engagement with manufacturing equipment, materials, documentation and operations.
• Work may involve site visits across multiple MDG facilities.
• The position may involve exposure to airborne particles and chemicals used in fermentation production facilities.
• The role requires the ability to manage changing priorities while maintaining a safety-, quality- and improvement-focused approach.

Minimum Qualifications

• Bachelor's degree in engineering, biotechnology, biology, microbiology, chemistry, or a related scientific or technical field.
• Two to five years of relevant experience in a manufacturing environment, such as biotechnology, fermentation, pharmaceutical, food, chemical processing, or related industry.
• Experience working in a GMP-compliant or document-controlled production setting.
• Demonstrated ability to troubleshoot process or equipment issues using data, observation, and structured problem-solving methods.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a cross-functional manufacturing environment.

Preferred Qualifications

• Hands-on experience with fermentors, centrifuges, freeze dryers, spray dryers, pumps, sensors, control systems, or related production equipment.
• Experience supporting validation, change control, deviation investigations, CAPA, root cause analysis, or regulatory audit readiness.
• Experience in fermentation, biologics, food production, pharmaceutical manufacturing, or other regulated production environments.
• Familiarity with continuous-improvement tools such as standard work, process mapping, 5S, Lean, or statistical process monitoring.

Technical Skills

• Ability to develop and maintain SOPs, work instructions, validation documents, equipment records, and process documentation.
• Ability to collect, organize, trend, and interpret production and equipment-performance data.
• Working knowledge of GMP, documentation control, validation practices, and manufacturing quality systems.
• Proficiency with Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.
• Ability to read and interpret equipment documentation, process records, schematics, and engineering change notices.

Non-Technical Skills

• Strong analytical, organizational, and problem-solving skills.
• Detail-oriented, methodical, and committed to accuracy, safety, and quality.
• Effective communicator with the ability to train and support production personnel.
• Collaborative, professional, and capable of working across Engineering, Manufacturing, Quality, and Operations.
• Adaptable and solutions-oriented in a fast-paced production environment.

Licenses/Certifications

• None required.
• Valid driver's license and reliable transportation preferred for travel between MDG sites.

Physical & Safety Requirements

• Ability to stand, walk, sit, and use a computer for prolonged periods.
• Ability to work on the production floor and engage directly with equipment and operations.
• Ability to occasionally lift up to 50 pounds, with or without reasonable accommodation.
• Adherence to all company safety procedures, GMP requirements, PPE requirements, and facility-access protocols.

Disclaimer

Adherence to all food safety procedures as per FDA regulations, including the FDA Food Safety Modernization Act (FSMA) or any other applicable federal, state, or local food safety regulations.