Cresilon
Headquartered in Brooklyn, New York, Cresilon, Inc. is a privately-held medical device company focused on hemostatic technologies that improve wound care and advance the standard of medical treatments$1. .$1
51 - 200
Manager Process Engineering (Chemical Processing & Medical Device Manufacturing)
August 10
🏢 In-office - Brooklyn
Cresilon
Headquartered in Brooklyn, New York, Cresilon, Inc. is a privately-held medical device company focused on hemostatic technologies that improve wound care and advance the standard of medical treatments$1. .$1
51 - 200
Description
• 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 realization. Provide 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 successful process transfer and implementation. • 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 and in adherence to OSHA, NFPA, and other applicable safety codes. • Contributes to strategic planning by evaluating and projecting future process and facility needs, including proposing options to achieve them. • Analyze facility needs, plans, and budgets 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. • 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, yield and overall cost, working closely with 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 experience in process development and process implementation to manufacturing environments is required. Preferred expertise is ideally in chemical/polymer processes and in controlled manufacturing environments(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 strongly preferred. • 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.
Benefits
• Competitive annual base salary range of $130,000 - $190,000, depending upon job level and qualifications. • Paid Vacation, Sick, & Holidays • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage • Company Paid Life and Short-Term Disability Coverage • Work/Life Employee Assistance Program • Monthly MetroCard Reimbursement • 401(k) & Roth Retirement Savings Plan with company match up to 5%
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