About Us:
Microbial Discovery Group (MDG) is an R&D-driven product development and Bacillus fermentation company. We apply Real Science to a Trusted Process, yielding Proven Success for our partners. At MDG, we recognize the need for sustainable solutions to the world's largest problems, and we work to solve them as part of our mission to Feed, Clean, Save the World. As a member of our team, your ideas and innovations are integral to who we are. Come grow with us! Position Summary :
The Process Principal - Fermentation position will be responsible for validation of
manufacturing processes and equipment. The position will collaborate with multiple
departments in developing and implementing process efficiencies in bioreactor operations,
centrifugation, freeze drying, spray drying and other downstream manufacturing processes. Responsibilities: Lead the development, review and optimization of standard operating procedures (SOP) and work instructions (WIs) for upstream and downstream manufacturing processes, ensuring clarity, accuracy, and compliance with regulatory guidelines. Collaborate with cross-functional teams, including R&D, engineering, quality control, and manufacturing, to gather input and insights for documentation. Prepares protocols for performance testing of new and modified manufacturing equipment, processes, and systems. This includes participating in equipment installations, validation, and start-up. Train and educate manufacturing personnel on new and existing SOPs and WIs, facilitating smooth implementation and adherence to best practices. Continuously assess, troubleshoot and improve fermentation operations. Identify areas for efficiency enhancement and propose and implement necessary process updates. Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications. Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices. Serve as a subject matter expert (SME) on process documentation, providing guidance and support for troubleshooting and resolving technical issues. Identifies root causes of production problems. Consults with management, assesses client requirements, and studies product characteristics to select validation objectives and standards. Stay up-to-date with industry best practices and regulatory changes, ensuring that SOPs remain compliant and reflect the latest advancements in the field. Keep up to date on current literature and trends in the state of the art of fermentation, freeze drying, spray drying and downstream processing. Performs other related duties as assigned. Qualifications: Knowledge, Skills, Abilities Validation of equipment and processes, audits and regulatory experience. Depth of experience working and succeeding in a document change controlled, regulated, cGMP production environment. Ability to utilize schematics such as P&IDs and understand or rapidly learn basic function and mission critical parameters of most processing equipment and automation. Hands-on mechanical aptitude, microbiology, and engineering skill. Very meticulous and methodical in problem solving, validation and root cause analysis. Detail-oriented with proven organization and coordination skills and continuous improvement mindset. Strong written and oral communication skills. Must be able to work as a part of inter and intra-departmental teams and change review board. Education, Training, Experience B.S. in Chemical Engineering, Biotechnology and 5 > years of relevant manufacturing experience. Chemical process, biotechnology, food, fermentation, or pharmaceutical manufacturing experience. Hands-on experience with bioreactor operations, centrifuges, freeze dryers spray dryers. Position is onsite and involves travel to MDG's fermentation and production facilities. Work Environment and Physical Requirements: Majority of work is conducted in a temperature-controlled office environment and may require extended periods of sitting. Work may include occasional lifting (up to 30 lbs.). May be exposed to airborne particles and chemicals used in fermentation production facilities. Safety Requirements: Adherence to all company safety procedures and regulations to maintain a safe working environment.
