Location: Delaware
Reports To: Chief Technical Officer (CTO)
Position Overview
We are seeking an experienced Engineering Manager to lead GMPLI’s engineering team, ensuring our state-of-the-art, digitally integrated facility operates at peak performance. This role will oversee the design, implementation, and optimization of systems that support the production of GMP-grade water, media, and buffer solutions. The Engineering Manager will collaborate closely with cross-functional teams to deliver projects on time, within budget, and in compliance with GMP and global regulatory standards.
Key Responsibilities
- Lead and mentor engineering teams in support of facility operations, equipment reliability, and process optimization.
- Oversee design, installation, and commissioning of new systems and process equipment.
- Partner with Quality, Validation, and EHS teams to ensure systems meet GMP and safety requirements.
- Drive continuous improvement initiatives to enhance efficiency, reduce downtime, and improve product quality.
- Develop engineering project plans, budgets, and timelines, reporting progress to the CTO.
Qualifications
- Bachelor’s degree in Engineering (Mechanical, Chemical, or related field). Master’s preferred.
- 8+ years of engineering experience in pharmaceutical, biotech, or life sciences manufacturing.
- Proven leadership of cross-functional engineering teams.
- Strong understanding of GMP, FDA, and global regulatory standards.
- Experience with water systems, buffer/media preparation, or sterile manufacturing preferred.
Key Competencies
- Leadership & Mentoring
- Regulatory Compliance Expertise
- Project Management Excellence
- Innovation & Continuous Improvement
- Cross-Functional Collaboration