Process Specialist

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.

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