Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. They have created a hemostatic device that can instantly stop traumatic bleeding.
The Manufacturing Process Engineering Manager is responsible for overseeing all aspects of process engineering for Cresilon including, but not limited to, directing all manufacturing 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 facility maintenance operations, facilities design/renovation, construction and repair management, especially as it pertains to process implementation. This role reports directly to the Vice President of Technology.
Responsibilities:
- Oversee all process engineering activities including process development/implementation process improvements, process scale-ups, process technology transfers and process validations.
- Oversee all facilities engineering modifications, including impact to all aseptic manufacturing facility infrastructure, HVAC/major mechanical equipment, electrical, plumbing, roofing, utilities, and other infrastructure systems.
- 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.
- Lead the expansion of Cresilon’s manufacturing locations, including site selection, securing bids, managing contracts, oversight of all execution activities.
- Play a lead role in technology transfer, scale-up and process characterization & validation.
- Manage projects and schedule and lead execution of regular facility shut-downs.
- 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 in accordance with company policies, procedures, and applicable regulatory standards.
- Ensure effective selection, training, development, and performance management of the manufacturing team to meet business needs.
