Manager Process Engineering (Chemical Process / Medical Device)

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.

Description:

The Process Engineering Manager is responsible for overseeing all aspects of process engineering for Cresilon including, but not limited to, directing all process development, process improvement, process scale-up, tech transfers, process validations, process implementations including the harmonization into the facility engineering systems, procedures and practices to ensure proper manufacturing environment, in compliance with all state, federal and regulatory governing agencies. They will also have some involvement in facility maintenance operations and facilities design/renovation especially as it pertains to process implementation. This role reports directly to the Vice President of Technology.

Job Responsibilities:

• Oversee all process engineering activities including process development/implementation process improvements, process scale-ups, process technology transfers, and process validations.
• Act as a technical thought leader in process engineering, facilities engineering, and equipment reliability, including providing technical expertise and scientific leadership in troubleshooting, root cause analysis, and data trending toward continued manufacturing process and facility improvements.
• Play a lead role in technology identification, scale-up, and process characterization & validation, including transfer.
• Support facilities engineering modifications as required for process implementation including impact to all aseptic manufacturing facility infrastructure, HVAC/major mechanical equipment, electrical, plumbing, roofing, utilities, and other infrastructure systems. Lead execution of regular facility shutdowns.
• Ensure all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives as well as in adherence to OSHA, NFPA, and other applicable safety codes.
• Contributes to strategic planning by evaluating and projecting future process and facility needs and proposing options to achieve them.
• Analyze facility needs, plan, and budget for expenditures in collaboration with senior management. Manage the approved capital and facilities-related expense budget to ensure that all budgets and schedules are met.
• Implement maintenance strategies to optimize buildings, mechanical equipment, and other utilities.
• Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.
• Ensure that all budgets, schedules, and performance requirements are met.
• Improve product quality and cost through interaction with both internal personnel and external suppliers.
• Apply LEAN and Six Sigma principles to manufacturing operations, with an emphasis on a culture of continuous improvement.
• Document all cGMP activities following company policies, procedures, and applicable regulatory standards.
• Ensure effective selection, training, development, and performance management of the manufacturing team to meet business needs.
• Other duties may be assigned as deemed necessary by management.

Requirements

• Bachelor’s degree in chemical engineering, biomedical engineering, materials engineering, or equivalent required.
• MS degree in a closely related technical field or MBA preferred.
• 5+ years of manufacturing process development and implementation experience is required, ideally in chemical/polymer process and controlled environment manufacturing (cGMP, aseptic, etc.)
• A minimum of 5 years of direct management experience is required, with the ability to manage engineers, scientists, and technicians and influence, motivate, and drive technical rigor.
• Hands-on, roll-up-your-sleeves approach with a high sense of urgency and drive for results, balancing creativity with implementation.
• Expertise in technical process design, development, implementation, and process technology transfer with a thorough understanding of regulatory requirements.
• Experience in chemical and polymer processes