Director, Engineering - Military veterans preferred

Nephron Pharmaceuticals


Description:

Corporate Statement:

Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

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Job Purpose:

The Director of Engineering is a strategic leadership role responsible for overseeing all engineering functions within our pharmaceutical Blow Fill Seal manufacturing facility. This position will lead a team of engineers and technical professionals, ensuring the efficient, safe, and compliant operation of our production equipment and facilities. The Director of Engineering will drive continuous improvement initiatives, manage capital projects, and provide technical expertise to support the company's growth and operational objectives.

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Essential Duties and Responsibilities:

Ø Work with VP of Engineering to develop process development studies.

Ø Work with VP of Engineering to generate protocols and summary analysis of results for process changes or new products.

Ø Work with VP of Engineering to ensure manufacturing operations adhere to all industry regulations, including GMP, FDA, and internal quality standards. Perform routine audits and inspections to ensure compliance.

Ø Work with VP of Engineering to support engineering projects, including the design and implementation of new processes or systems. Develop project plans, timelines, and budgets to ensure successful completion.

Ø Team member and subject matter expert on cross functional team to develop Process Development Studies. Responsible for protocol generation and summary analysis of results for process changes or new products.

Ø Team member and subject matter expert for the design and implementation of new equipment and equipment modifications to help improve safety, Quality, reliability, and throughput.

Ø Responsible for implementation of new processes while maintaining cGMP compliance.

Ø Team member and subject matter expert for the generation of User Requirement Specification documents for new equipment.

Ø Manages capital projects from a small to medium scope requiring moderate coordination. Ability to manage several assignments (project & process duties) simultaneously is required.

Ø Ensure all equipment is in compliance with established safety standards.

Ø Responsible for acquiring and reviewing equipment/materials quotations. Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment.

Ø All other duties as assigned or apparent.

Ø Ability to interact with all levels of management.

Ø Ability to work in collaboration with machinists and technicians, etc. in the modification, adjustment, removal and installation of new or existing equipment as required.

Ø As required within the scope of the project, responsible for associated documentation: Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc.

Ø Leads process improvement activities. Must have ability to design and implement machine modifications.

Supplemental Functions:

Ø Performs other similar duties as required.

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Knowledge & Skills:

Ø Work with VP of Engineering to design, evaluate, and optimize pharmaceutical manufacturing processes to increase efficiency, reduce waste, and improve quality while adhering to regulatory requirements.

Ø Identify and resolve issues with manufacturing equipment, processes, or systems. Provide technical support for production-related challenges.

Ø Work closely with operations, quality control, maintenance, validation, and other departments to ensure smooth coordination and timely completion of projects.

Ø Ability to successfully prioritize and manage large projects, deadlines, and tasks while working independently or with a team

Ø The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals

Ø Willingness to participate in training and gain other certifications as needed.

Ø Familiarity with the following processes: liquid dispense, sterile pathway, autoclave cycle development, leak detection, pick-n-place, printing/labeling

Ø Highly organized with the ability to manage multiple projects and changing priorities

Ø Assists with additional work duties or responsibilities as evident or required.

Education / Experience:

Ø Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field) is required. An advanced degree is preferred.

Ø Minimum of 15 years of progressive engineering experience in a pharmaceutical manufacturing environment, with a strong focus on sterile products and aseptic processing.

Ø Minimum of 10 years of experience in a supervisory or management role, leading a team of technical professionals.

Ø Extensive knowledge and experience with Blow Fill Seal (BFS) technology and its associated equipment and processes.

Ø Demonstrated leadership experience with a proven ability to build and manage high-performing teams.

Ø Strong understanding of cGMP regulations, FDA guidelines, and other relevant pharmaceutical industry standards.

Ø Proven track record of successfully managing capital projects from inception to completion.

Ø Excellent problem-solving, analytical, and decision-making skills.

Ø Strong communication, interpersonal, and presentation skills.

Ø Experience with automation systems (PLC, SCADA) and process control.

Ø Proficiency in computer applications, including CAD software and MS Office Suite.

Ø Experience with lean manufacturing and continuous improvement methodologies (e.g., Six Sigma) is a plus.

Licensing and Certification:

Ø Six Sigma certification (greenbelt or blackbelt) preferred.

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Working Conditions / Physical Requirements:

Ø Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.

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The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description.

Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

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