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.

• 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 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.

• 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.

• Hands‑on experience with fer mentors, 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…