Mantell Associates
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.