Process Engineer III

1 day ago

Boulder, United States KBI BioPharma Full time
Position Summary:

We are seeking a skilled Engineer III to join our team and support the manufacturing equipment at our biopharmaceutical manufacturing facility. In this hands-on role, you will be responsible for the maintenance, optimization, and troubleshooting of critical equipment, including UFDF (Ultra-Filtration/Diafiltration) systems, Centrifuges, Homogenizers, Fermenters, and other process equipment. You will collaborate with cross-functional teams to ensure that manufacturing systems operate efficiently, reliably, and in compliance with cGMP (current Good Manufacturing Practices) and regulatory standards.

Manufacturing Equipment Management:

Oversee the performance, maintenance, and troubleshooting of key manufacturing equipment, including UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers.

Ensure equipment operates at peak performance and aligns with regulatory requirements and safety standards.

Perform preventive maintenance, inspections, and system optimizations to ensure continuous operation of equipment.

Deviation Investigations:

Lead investigations into any deviations related to manufacturing equipment.

Identify root causes and develop corrective and preventive actions (CAPA) to resolve issues.

Support documentation of findings through the Quality Management System (QMS) and work with cross-functional teams to ensure proper resolution.

Change Management:

Support engineering changes related to manufacturing equipment, ensuring compliance with Change Control procedures.

Collaborate with other engineering and operational teams to implement changes effectively and minimize disruption.

System Performance Optimization:

Continuously assess and improve system performance, focusing on equipment reliability, longevity, and efficiency.

Work on data analysis and reliability improvements for manufacturing equipment to minimize downtime and enhance productivity.

Regulatory Compliance:

Ensure compliance with cGMP, safety, and environmental standards in the operation and maintenance of equipment.

Assist with creating and maintaining Standard Operating Procedures (SOPs) for equipment operation and ensure they remain up to date with regulatory requirements.

Cross-Functional Collaboration:

Collaborate with operations, quality assurance, validation, and manufacturing teams to ensure smooth integration of equipment and processes.

Work with external suppliers and contractors to ensure timely, cost-effective, and high-quality equipment repairs or upgrades.

Documentation and Reporting:

Maintain detailed records of all engineering activities, including maintenance, investigations, corrective actions, and changes to equipment or processes.

Ensure all documentation is accurate, cGMP-compliant, and audit-ready.

Requirements:

Education:

Bachelor's degree in Engineering, Biotechnology, Biochemical Engineering, or a related discipline. A Master's degree is a plus.

Experience:

At least 5 years of engineering experience in a biopharmaceutical manufacturing environment.

Hands-on experience with manufacturing equipment such as UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers.

Experience in troubleshooting, maintenance, and optimization of complex process equipment.

Technical Skills:

Solid understanding of biopharmaceutical manufacturing processes and equipment.

Familiarity with cGMP regulations and industry standards for manufacturing equipment.

Experience with process automation or control systems.

Proficiency in Quality Management Systems (QMS), Change Control, and CAPA processes.

Proficiency in engineering software, including AutoCAD, Microsoft Office Suite, and other relevant tools.

Problem-Solving and Analytical Skills:

Strong troubleshooting abilities and experience performing root cause analysis for equipment-related issues.

Ability to develop and implement corrective actions and process improvements.

Communication Skills:

Strong verbal and written communication skills with the ability to effectively collaborate with internal teams, external contractors, and vendors.

Project Management:

Strong organizational skills and experience managing multiple projects concurrently, ensuring timely and cost-effective completion.

Attention to Detail:

Meticulous attention to documentation, compliance, and equipment management to ensure high standards of quality.

Preferred Skills:

Prior experience in a leadership or mentoring role is a plus.

Familiarity with advanced process control systems or automation.

Experience working in a regulated environment, particularly within the pharmaceutical or biotechnology industries.

Note: This role is a full time onsite position is not hybrid or remote.

Salary Range: $89,788 to $123,459

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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