Manager Process Engineering (Chemical Process / Med Device Manufacturing)

at  Cresilon Inc

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 in the development and scale-up of Cresilon’s hemostatic medical devices. This includes, but is 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. The ideal candiate will have expereince in chemical or polymer materials processing and experience in biotechnological applications. This role reports directly to the Vice President of Technology.

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 processes and in a 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, including formulation and purification is required.
• Experience with semisolid aseptic formulation and syringe filling lines is strongly preferred.
• Demonstrated experience managing third-party vendors and service providers.
• Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (e.g., ISO 13485) is preferred.
• Strong project management and organizational skills, including attention to detail and multi-tasking skills.
• Demonstrated ability to execute priorities in a fast-paced environment, working under pressure with tight timelines with the ability to maintain a sense of priorities focus, and urgency.
• Requires strong leadership and organizational skills including attention to detail and multi-tasking skills.
• Working knowledge of industry-standard schematic capture and mechanical design CAD tools preferred
• Ability to identify and analyze complex technical problems and implement innovative solutions is required.
• Ability to extract key facts from complex information and present concise summaries to management.
• Knowledge of Lean Manufacturing principles and Six Sigma Black Belt certification strongly preferred.
• Demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.
• Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) are required.
• Experience working under pressure with tight timelines with the ability to maintain a sense of priorities focus and urgency.
• Extensive experience with using project management and/or collaboration tools (e.g., Microsoft Project) required. Strong working knowledge of Microsoft Office is required.
• Legal authorization to work in the United States is required.

• 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.