Senior Specialist Engineering, Sterile/Liquids (Onsite)
$117,000–$184,200 year
On-siteWest Point, Pennsylvania, United States
Job Summary
Manage sterile process manufacturing and formulation development for clinical, stability, and developmental vaccine and therapeutic protein supplies at the Sterile/Liquids Pilot Plants. Provide technical input on facility operations, oversee manufacturing project management, and apply GMP expertise to ensure timely availability of batches for clinical development and process optimization. Serve as the primary interface with development scientists for sterile liquid batch production, handling deviation management, process improvement projects, and implementation of new technologies. Lead cross-functional teams in process design, batch documentation, and investigations while maintaining detailed technical writing for protocols and batch records.
Required Qualifications
- Bachelor's of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field
- Minimum of 3 years in a technical or operations support role
- Sterile process manufacturing and/or formulation development
- Knowledge of manufacturing equipment and Good Manufacturing Practices
- Project management
- Analytical problem-solving skills
- Cross functional leadership
- Technical writing – including batch documentation, investigations, protocols
- Adaptability
- Analytical Testing
- Batch Production Records
- Biologics
- Chemical Engineering
- Chemistry
- Clinical Manufacturing
- Cross-Functional Project Management
- Data Analysis
- Detail-Oriented
- Deviation Management
- Documentation Preparation
- Drug Formulations
- Equipment Qualification
- Functional Management
- Good Manufacturing Practices (GMP)
- Manufacturing
- Manufacturing Processes
- Problem Identification
- Process Design
- Process Development (PD)
- Process Engineering
- Process Hazard Analysis (PHA)
- Process Optimization
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