Director, Engineering

Nephron Pharmaceuticals • West Columbia, SC

263d

About The Position

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.

Requirements

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field) is required.
• Minimum of 15 years of progressive engineering experience in a pharmaceutical manufacturing environment, with a strong focus on sterile products and aseptic processing.
• Minimum of 10 years of experience in a supervisory or management role, leading a team of technical professionals.
• Extensive knowledge and experience with Blow Fill Seal (BFS) technology and its associated equipment and processes.
• Demonstrated leadership experience with a proven ability to build and manage high-performing teams.
• Strong understanding of cGMP regulations, FDA guidelines, and other relevant pharmaceutical industry standards.
• Proven track record of successfully managing capital projects from inception to completion.
• Excellent problem-solving, analytical, and decision-making skills.
• Strong communication, interpersonal, and presentation skills.
• Experience with automation systems (PLC, SCADA) and process control.
• Proficiency in computer applications, including CAD software and MS Office Suite.

Nice To Haves

• An advanced degree is preferred.
• Experience with lean manufacturing and continuous improvement methodologies (e.g., Six Sigma) is a plus.
• Six Sigma certification (greenbelt or blackbelt) preferred.

Responsibilities

• Work with VP of Engineering to develop process development studies.
• Generate protocols and summary analysis of results for process changes or new products.
• Ensure manufacturing operations adhere to all industry regulations, including GMP, FDA, and internal quality standards.
• Perform routine audits and inspections to ensure compliance.
• Support engineering projects, including the design and implementation of new processes or systems.
• Develop project plans, timelines, and budgets to ensure successful completion.
• Act as a subject matter expert on cross-functional teams for process development studies.
• Responsible for protocol generation and summary analysis of results for process changes or new products.
• Design and implement new equipment and equipment modifications to improve safety, quality, reliability, and throughput.
• Implement new processes while maintaining cGMP compliance.
• Generate User Requirement Specification documents for new equipment.
• Manage capital projects from a small to medium scope requiring moderate coordination.
• Ensure all equipment is in compliance with established safety standards.
• Acquire and review equipment/materials quotations.
• Complete or supervise the completion of necessary designs, drawings, calculations, and specifications on associated equipment.
• Interact with all levels of management.
• Collaborate with machinists and technicians in the modification, adjustment, removal, and installation of new or existing equipment.
• Responsible for associated documentation: Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc.
• Lead process improvement activities.
• Design and implement machine modifications.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree