Process Engineering Manager

2 weeks ago

Brooklyn New York, United States Cresilon, Inc. Full time

Cresilon, Inc. is a pioneering biotechnology firm located in Brooklyn, specializing in the creation, production, and distribution of hemostatic medical devices that leverage the company’s unique hydrogel technology.

Our innovative plant-based solutions have transformed the industry standard by effectively halting traumatic and surgical bleeding within moments, eliminating the necessity for prolonged manual pressure.

We focus on developing products aimed at veterinary, human trauma, and surgical applications, with a mission centered on saving lives. For more information about our organization, please visit our website.



Position Overview:

The Process Engineering Manager plays a crucial role in supervising all facets of process engineering related to the development and scaling of Cresilon's hemostatic medical devices.

This role encompasses directing process development, scale-up operations, technology transfers, validations, enhancements, and implementations within Cresilon's internal manufacturing facilities and with Contract Development and Manufacturing Organizations (CDMOs).

Success in this position hinges on the effective integration of processes into existing engineering systems, ensuring compliance with all relevant state, federal, and regulatory agencies.

Additionally, the role may involve participation in facility maintenance and design/renovation projects, particularly concerning process implementation.



Key Responsibilities:
  • Oversee all process engineering functions, including development, implementation, improvements, scale-ups, technology transfers, and validations.
  • Serve as a technical authority in process and facilities engineering, providing scientific leadership in troubleshooting and data analysis to enhance manufacturing processes.
  • Lead initiatives in technology identification, scale-up, and process validation, ensuring successful transfer and implementation.
  • Support modifications to facilities engineering as necessary for process implementation, impacting all aspects of aseptic manufacturing infrastructure.
  • Manage regular facility shutdowns and ensure compliance with established policies, OSHA, NFPA, and other safety standards.
  • Contribute to strategic planning by assessing future process and facility requirements and proposing viable solutions.
  • Collaborate with senior management to analyze facility needs and budgets, managing capital and operational expenses effectively.
  • Ensure adherence to specifications, standard operating procedures (SOPs), and FDA regulations.
  • Enhance product quality, yield, and cost-effectiveness through collaboration with internal teams and external suppliers.
  • Implement LEAN and Six Sigma methodologies to foster a culture of continuous improvement.
  • Document all cGMP activities in accordance with company policies and regulatory standards.
  • Facilitate the selection, training, and performance management of the manufacturing team to align with business objectives.
  • Perform additional duties as assigned by management.


Qualifications:
  • Bachelor's degree in chemical engineering, biomedical engineering, materials engineering, or a related field is required.
  • A Master's degree in a relevant technical discipline or an MBA is preferred.
  • Minimum of 5 years of experience in process development and implementation within manufacturing settings is essential, with a focus on chemical/polymer processes and controlled environments (cGMP, aseptic, etc.).
  • At least 5 years of direct management experience, with the capability to lead engineers, scientists, and technicians effectively.
  • Hands-on approach with a strong sense of urgency and a commitment to results, balancing creativity with practical implementation.
  • Proficiency in technical process design, development, and regulatory compliance.
  • Experience with semisolid aseptic formulation and syringe filling processes is highly desirable.
  • Demonstrated ability to manage third-party vendors and service providers.
  • Strong understanding of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (ISO preferred).
  • Proven capability to prioritize tasks in a fast-paced environment while maintaining focus and urgency.
  • Excellent leadership, organizational, and project management skills, with a keen attention to detail.
  • Familiarity with industry-standard CAD tools and project management software is preferred.
  • Ability to analyze complex technical challenges and devise innovative solutions.
  • Strong communication skills, both written and verbal, with the ability to collaborate effectively with diverse teams.
  • Legal authorization to work in the United States is required.


Cresilon, Inc. is an equal opportunity employer committed to fostering diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

We make hiring decisions based solely on qualifications, merit, and business needs.



Benefits:
  • Competitive annual base salary range of $130,000 - $190,000, based on job level and qualifications.
  • Paid vacation, sick leave, and holidays.
  • Comprehensive medical, dental, and vision insurance.
  • Flexible spending accounts for dependent and healthcare expenses, as well as commuter and parking benefits.
  • Company-paid life and short-term disability coverage.
  • Work/life employee assistance program.
  • Monthly MetroCard reimbursement.
  • 401(k) and Roth retirement savings plan with company match up to 5%.

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