Job DescriptionWe are seeking a highly experienced and technically accomplished Principal Engineer to serve as the technical leader for Oral Solid Dosage (OSD) platform within our Manufacturing Science & Technology (MSAT) organization.
This role will lead the site's OSD commercial manufacturing technical support activities, technology transfers, and continuous improvement initiatives. The Principal Engineer will be responsible for solving complex technical challenges, strengthening process understanding, and ensuring robust, compliant, and efficient manufacturing processes.
This position is designed for a deep technical expert who thrives in solving complex problems, influencing cross-functional teams, and driving meaningful improvements in cost, yield, and product quality.
ResponsibilitiesTechnical Leadership & Platform Development
- Serve as the site-wide technical authority for OSD manufacturing processes
- Define and evolve the OSD technical platform, including process standards and best practices
- Establish strong process knowledge and improve control strategies across products and unit operations
- Act as the site's technical representative for new product entry on cross-functional development programs
Manufacturing Support & Troubleshooting
- Lead complex investigations related to process deviations, atypical events, and product quality issues
- Provide hands-on technical support to manufacturing operations
- Perform structured root cause analysis and implement sustainable corrective actions
Technology Transfer & Scale-Up
- Support technical activities for new product introductions (NPI) and technology transfers from R&D into the site
- Ensure effective translation of process knowledge from development to commercial manufacturing
- Lead both intra and inter site tech transfer of established commercial processes
- Support process validation and lifecycle management strategies
Continuous Improvement
- Drive initiatives to improve yield, throughput, and cost of goods (COGs)
- Apply data-driven and scientific approaches to enhance process robustness
- Identify and implement process and equipment optimization opportunities
Cross-Functional Collaboration
- Partner with Manufacturing, Quality, Engineering, PharmDev, Technical Operations and Validation to ensure successful execution of technical initiatives
- Serve as a trusted technical advisor across the organization
Regulatory & Compliance Support
- Ensure all activities meet GMP and regulatory expectations
- Support regulatory submissions, inspections, and audits as a subject matter expert
- Author and review technical documentation, investigations, and reports
QualificationsEducation and Experience
- Master's degree in Engineering, Pharmaceutical Sciences, or related field (required)
- Ph.D. (preferred)
Experience
- Minimum 15 years of experience in pharmaceutical manufacturing or development
- Significant experience in oral solid dosage processes and technologies
- Proven track record in:
- Complex problem-solving and troubleshooting
- Technology transfer and scale-up
- Process optimization and continuous improvement
Technical Skills
- Strong expertise in OSD unit operations (e.g., blending, granulation, compression, coating; both cosmetic and functional)
- Experience with data analysis, statistics, and process modeling
- Deep understanding of GMP and regulatory requirements
Leadership Attributes
- Demonstrated ability to lead without authority and influence cross-functional teams
- Strong communication skills, with the ability to translate complex concepts into practical solutions
- Ability to operate effectively in a fast-paced, technically complex environment
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