Senior Engineering Manager

Mantell Associates is partnered with a leading CDMO specializing in sterile drug product manufacturing for global pharmaceutical and biotechnology partners. With advanced aseptic processing capabilities and a strong regulatory track record, they are seeking an experienced Senior Engineering Manager to support manufacturing engineering operations at their East Coast facility.

This is a strong opportunity to join a growing drug product CDMO on the East Coast and play a pivotal role in strengthening engineering operations, enhancing manufacturing performance, and supporting the successful delivery of sterile products to global markets.

Senior Engineering Manager - Responsibilities:

• Provide technical oversight for sterile filling and drug product manufacturing operations to ensure consistent delivery of products meeting defined quality specifications
• Partner cross-functionally with Manufacturing, Quality, Maintenance, and Supply Chain to resolve complex operational and technical challenges
• Lead process optimisation initiatives, including equipment upgrades, risk assessments, and engineered improvements to enhance throughput, reliability, and compliance
• Oversee the design and modification of manufacturing components and change parts, utilizing CAD tools where appropriate
• Review and approve critical manufacturing documentation, including batch records, protocols, engineering reports, and quality documentation
• Lead and support deviation investigations, CAPAs, and root cause analyses related to aseptic and fill-finish operations
• Drive technology transfer activities for new products, equipment, and processes into commercial manufacturing
• Implement and maintain process monitoring tools, performance metrics, and data trending systems to strengthen process control
• Support equipment qualification, process validation, and ongoing lifecycle management activities
• Ensure full compliance with FDA, EU GMP, and other applicable regulatory standards
• Mentor and develop engineering staff, fostering a high-performance and solution-oriented culture

Senior Engineering Manager - Requirements:

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related technical discipline; advanced degree preferred
• Extensive experience within sterile drug product manufacturing, ideally in a pharmaceutical or CDMO setting
• Strong expertise in aseptic processing, filling operations, terminal sterilization, and/or lyophilization
• Proven leadership experience managing engineering teams and complex cross-functional projects
• Deep understanding of cGMP requirements and FDA regulatory expectations
• Experience supporting validation programs, equipment qualification, and technical transfers
• Strong technical writing, analytical, and structured problem-solving capabilities
• Experience with engineering design tools and CAD systems is advantageous
• Excellent communication skills with the ability to engage effectively with clients and executive stakeholders
• Ability to work on-site 4 days per week with flexibility to support critical manufacturing activities as required

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at \+44 (0)20 3854 7700\.