Sr. Fermentation Engineer

Donaldson is committed to solving the world’s most complex filtration challenges. Employing innovation and breakthrough solutions, we are advancing filtration for a cleaner world. We look for the best people to help us succeed, offering opportunities to learn, effect change, and make meaningful contributions at work and in our communities. This is a place where you can make a world of difference. Follow Us on LinkedIn: https://www.linkedin.com/company/donaldson/ Come work for an exciting biotechnology company with strong roots. Isolere Bio, Inc. located in Durham, NC, is Donaldson's latest addition to a growing list of biotechnology initiatives. Isolere Bio develops reagents that combine engineered biopolymers with tunable phase separation, with affinity ligands that confer the unique material properties to the biologic target of interest. The company offers a growing portfolio of purification solutions for a wide range of biologics, including AAV, lentivirus, mRNA, plasmid DNA and other viral particles. Isolere’s proprietary technology and processes create reagents that have significant competitive advantages – improving productivity, quality and reducing the overall cost of goods for increasingly complex biologic drugs, enabling accelerated and more affordable delivery of life-changing therapies to patients globally. www.isolerebio.com Combining Isolere’s deep expertise in liquid phase separation, and Donaldson’s filtration technology expertise, and global sales and manufacturing footprint, we are on a fast-track to develop and commercialize Isolere’s novel affinity liquid phase separation reagents for biologics purification. As a Sr Fermentation Engineer, you will collaborate closely with teams developing and deploying scalable fermentation-based bioproduction processes for the production of reagents and oversee the transfer of those processes to the pilot and manufacturing scale. Role Responsibilities: Apply fermentation knowledge to the review & update of design documentation (process flow diagrams, P&IDs, etc.) Coordinate & execute process validation activities for fermentation Verify process equipment & facilities satisfy design requirements. Ensure designs comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines Execute & coordinate all qualification activities included in the project (FAT, SAT, IQ, OQ, PQ) Support work packages in maintaining schedule & project milestone adherence Ensure coordination & collaboration between project & other site stakeholders Develop knowledge of risk assessment documents such as requirements risk assessments (RRA's) Support update, development & design adherence to requirement specification documents Participation in review & update of QRM risk assessments such as closed-system, cross-contamination, contamination & facility flows Provide design basis information for accurate process scheduling & capacity calculations Support team in ensuring installed design adheres to process requirements Provide technical support of the operating facility to meet business goals Coach & mentor less experienced members of the team Support development & implementation of change requests during commissioning & operation Minimum Qualifications: Bachelor's degree in engineering, biology, or related field 3- 5 years of experience in Upstream Engineering and Fermentation Operations Knowledge of policies/standards (cGMP, ISO 9001/13485, 21CFR820). Experience working closely with bioreactors and scale up of equipment from ~20L to ~500L. Demonstrated ability to successfully complete projects on time and within budget. Communicate effectively with vendors and internal cross-functional teams. Preferred Qualifications: Six Sigma training and certification Demonstrated experience in Microbial Fermentation processes. Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM). Ability to independently apply advanced engineering techniques & analysis within the discipline. Strong project management skills Excellent oral & written communication skills Proven expertise in planning/organization/execution of maintenance activities & following up on results. Creating &/or revising the work plan for complex problems being resolved by cross functional teams. Physical & Other Requirements: Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility. Routinely operates & inspects manufacturing equipment using hands. Constantly positions oneself to transfer materials within manufacturing environment. Frequently moves about building(s) to access other personnel & operational areas. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Key words: fermentation, process engineer, manufacturing, biologics, biopharmaceutical, life sciences Come make a World of Difference! Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law. Donaldson Company helps solve some of the world's most complex filtration and contamination control challenges, and is one of the largest global providers of unique filtration technologies and high-quality filters and parts. Our filtration technologies and products are used every day, in a variety of industries and environments, including aerospace, agriculture, construction, food and beverage, manufacturing, mining, power generation, transportation and many more. Key to our success, our 14,000 employees support customers at sales, manufacturing and distribution centers from over 140 locations on six continents. The filtration market continues to grow. Customers' needs for filtration solutions continue to evolve. And the opportunities for our products and our people continue to expand. Learn more at www.donaldson.com.