Bioprocess Engineer

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…