Manager, Process Engineering

Position Summary:

We are seeking a highly skilled Engineering Manager to provide engineering support for the manufacturing equipment at our biopharmaceutical manufacturing facility. This leadership role will focus on ensuring the optimal performance, reliability, and compliance of key manufacturing systems, including UFDF (Ultra-Filtration/Depth Filtration), Centrifuges, Homogenizers, Fermenters and other process equipment. You will oversee a team of 3 engineers, driving improvements in equipment performance, maintenance, and troubleshooting, while ensuring adherence to cGMP (current Good Manufacturing Practices) and regulatory standards. The role will report into the broader Engineering team and collaborate closely with cross-functional teams to support the efficient and compliant operation of the manufacturing process.

Responsibilities:

Team Leadership:

• Manage and mentor a team of 3 engineers, providing direction and support to ensure successful project execution, efficient troubleshooting, and continuous improvement of manufacturing equipment.

Manufacturing Equipment Management:

• Oversee the maintenance, optimization, and troubleshooting of critical equipment in the manufacturing process, including UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps and other process equipment. Ensure that these systems are operating at peak efficiency and comply with regulatory standards.

Non-Conformance Investigations:

• Lead investigations for any non-conformances (NCs) related to manufacturing equipment. Identify root causes, propose corrective and preventive actions (CAPA), and ensure effective resolution through the Quality Management System (QMS).

Change Management:

• Manage engineering changes related to manufacturing equipment and systems, ensuring compliance with Change Control procedures. Collaborate with other teams to implement changes in a timely and cost-effective manner while minimizing disruption to operations.

System Performance Optimization:

• Continuously assess and improve system performance, ensuring equipment reliability and longevity. Work on preventive maintenance schedules, performance reviews, and reliability improvements for manufacturing equipment.

Regulatory Compliance:

• Ensure compliance with cGMP regulations, health, safety, and environmental standards in the operation and maintenance of manufacturing equipment. Support the creation and maintenance of Standard Operating Procedures (SOPs) for equipment operations.

Cross-Functional Collaboration:

• Work closely with internal teams, including operations, quality assurance, validation, and manufacturing, to ensure seamless integration and troubleshooting of equipment and systems. Collaborate with external suppliers and contractors to ensure the timely and cost-effective implementation of solutions.

Documentation and Reporting:

• Maintain accurate records of engineering activities, including investigations, corrective actions, equipment maintenance, and any changes to equipment or processes. Ensure that all documentation complies with cGMP requirements and is 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, with hands-on experience working with manufacturing equipment such as UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps and other processing equipment.
• Preferably 2+ years of leadership experience, including managing a team of engineers.

Technical Skills:

• In-depth knowledge of biopharmaceutical manufacturing processes, equipment, and cGMP regulations.
• Experience with manufacturing equipment such as UFDF, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers.
• Experience with process automation or control systems in a biopharmaceutical manufacturing environment.
• Familiarity with Quality Management Systems (QMS), Change Control, and CAPA processes.
• Proficiency with engineering software (e.g., AutoCAD, Microsoft Office Suite).

Leadership and Team Management:

• Proven track record in managing and developing a team of engineers. Ability to provide guidance, prioritize tasks, and resolve issues effectively.

Problem-Solving and Analytical Skills:

• Strong troubleshooting skills with the ability to perform root cause analysis and develop effective corrective actions for equipment-related issues.

Communication Skills:

• Excellent verbal and written communication skills, with the ability to engage effectively with cross-functional teams and external suppliers or contractors.

Project Management:

• Strong project management skills, capable of managing multiple initiatives concurrently while ensuring timely completion and adherence to scope and budget.

Attention to Detail:

• A detail-oriented approach to documentation, compliance, and equipment management.

Salary Range: $111,331 - $153,080

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.