Bioprocess Engineer at EKF Diagnostics

South Bend, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

95000.0

Posted On

13 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbial Fermentation, Downstream Processing, cGMP Compliance, Process Validation, Equipment Troubleshooting, Chromatography, TFF Filtration, Lyophilization, SOP Development, Quality Management Systems, HMI Software, Process Scale-up, Mechanical Aptitude, Technical Leadership, Client Communication, Project Management

Industry

Medical Equipment Manufacturing

Description

Description SUMMARY OF POSITION: Provides technical leadership in microbial fermentation and bioprocess operations. This role involves a specialized focus on optimizing microbial fermentation and managing critical downstream process operations in a Contract Manufacturing Organization (CMO) environment. ESSENTIAL FUNCTIONS, included but not limited to: Provide technical subject matter expertise (SME) to support various site operations and ensure seamless production cycles. Collaborate cross-functionally to refine and optimize enzyme fermentation and downstream processing (DSP) workflows to improve yield and scalability. Hands-on operation of core bioprocessing systems, including large-scale fermentation vessels, chromatography skids, TFF/filtration units, and lyophilization equipment. Act as the primary technical resource for resolving complex process deviations and equipment malfunctions. Assist with the calibration and routine servicing of precision production instrumentation. Assist in the revision of Standard Operation Procedures (SOPs) and technical documentation to maintain high quality standards and audit readiness. Serve as the primary technical point of contact for external clients, effectively communicating process data, technical decision-making, and site-specific capabilities in a Contract Development and Manufacturing Organization (CDMO) setting. Define and lead the site-wide strategy for process and equipment validation (IQ/OQ/PQ), ensuring all systems meet rigorous operational standards. Design and implement PM programs for critical bioprocessing hardware to minimize downtime and extend equipment lifecycle. Ensure all activities strictly adhere to Company policies , cGMP guidelines, internal Standard Operating Procedures (SOPs), and the site’s Quality Management System (QMS). OTHER FUNCTIONS: Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area. Assist as needed in other areas of the company where training requirements have been completed. Perform other duties as assigned. SUPERVISORY RESPONSIBILITIES: None. TRAVEL: None. Requirements REQUIRED QUALIFICATIONS: Legally authorized to work in the United States. Bachelor of Science degree in an Engineering discipline (Chemical, Biochemical, Bioengineering, or Electrical) or a related Life Sciences field (Biotechnology, Biology, Chemistry). At least 2 years of hands-on experience in industrial bioprocessing or a related manufacturing field, with a proven track record of supporting production-scale operations. Demonstrated ability to operate within a highly regulated environment, ensuring all engineering activities maintain strict adherence to cGMP and ISO compliance requirements. Physically and technically capable of working with a variety of chemical reagents and biological materials (e.g., microbial cultures, enzymes) required for fermentation and downstream processing. Flexibility to work some limited off-shift and weekend hours in order to support all production shifts when needed. Strong mechanical aptitude with the ability to diagnose, disassemble, and repair complex bioprocessing hardware and fluid-handling systems. PREFERRED QUALIFICATIONS: Functional understanding of automated bioprocessing platforms; able to navigate HMI (Human Machine Interface) software to monitor, control, and optimize fermentation and DSP sequences. Industrial plant experience with a specific focus on process scale-up, troubleshooting, and continuous improvement (CI) initiatives. BASIC SKILLS AND ABILITIES: Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. Ability to work independently and as a member of various teams and committees. Detail oriented with a high level of accuracy, efficiency, and accountability. Strong organizational skills to meet goals and set priorities. Proactively identify problems and develop solutions to improve manufacturing operations and safety. Participate in cost-saving initiatives and maintain or improve product quality and yield. Proficient in MS Office Suite. Ability to operate related office equipment, such as computer, calculator, and copier. REASONING ABILITIES: Ability to apply logic and common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to define problems, collect data, establish facts, and draw valid conclusions. LANGUAGE SKILLS: Ability to read and interpret work related documents, procedures, and manuals. Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language. Good interpersonal skills such as ability to communicate effectively, internally, and externally at all levels and diverse personalities. MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents. VISUAL ACUITY: Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading. PHYSICAL DEMANDS: Must be able to wear and work in personnel protective equipment (PPE) as required. Light physical activity performing non-strenuous daily activities of a primarily administrative nature. Stationary position sitting for prolonged periods of time while utilizing standard office tools. Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper. The ability to hear, understand, and distinguish speech. Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations. Frequently lift and/or move up to 50 pounds. Frequently reaching for items above and below desk level. Occasionally required to climb or balance; squat, stoop, kneel, or crouch. ENVIRONMENT CONDITIONS: Well, lit, heated/air-conditioned indoor office setting with adequate ventilation. The noise level in the work environment is moderate. Periodic exposure to low temperatures in controlled refrigerators and/or freezers. Periodic exposure to high temperatures may occur when working with specific pieces of equipment. Some exposure to hazards or physical risks which require following basic safety precautions. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities, absent of undue hardship. To perform this job successfully, the incumbents will possess skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

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Responsibilities

Provides technical leadership in microbial fermentation and downstream process operations within a CDMO environment. Responsible for optimizing yields, managing equipment validation (IQ/OQ/PQ), and serving as the primary technical contact for external clients.