The Manufacturing Process Specialist will support the execution of manufacturing and quality systems with minimal supervision. This includes non-conformance management, process validation, procedure development, training, and new product introductions. The role requires strong scientific and operational expertise, analytical and troubleshooting skills, and a foundational understanding of compliance. The specialist may serve as the primary owner for specific production processes and support more complex systems as needed.
Key Responsibilities
- Initiate, revise, and approve manufacturing procedures to ensure alignment with current operations.
- Serve as document owner and contribute to the development of training materials.
- Provide technical training on scientific and operational aspects of the process.
- Support the establishment of process monitoring parameters and control limits.
- Collect and analyze process data; identify and implement process improvement opportunities.
- Provide troubleshooting support and assess floor operations to ensure optimal performance.
- Triage non-conformances within established timelines.
- Author investigation reports and execute corrective actions.
- Manage closure of NC/CAPA records and monitor incident trends.
- Review equipment/system root cause investigations and support trend evaluations.
- Assist in the development and execution of validation protocols and reports.
- Support data collection and analysis for validation activities.
- Participate in regulatory inspections and support new product introductions.
- Assess documentation, materials, training, and equipment needs for NPI.
- Provide project management support for process and equipment modifications.
- Assist with change control packages impacting manufacturing processes.
- Contribute to the assessment and implementation of special projects and cross-functional initiatives.
Requirements
- Master’s degree + 2 years of manufacturing operations experience OR
- Bachelor’s degree + 4 years of manufacturing operations experience OR
- Associate degree + 8 years of manufacturing operations experience OR
- High school diploma/GED + 10 years of manufacturing operations experience
Preferred Qualifications & Skills
- Experience supporting Drug Substance manufacturing processes
- Proficiency in process monitoring, data collection, and analysis
- Familiarity with GMP systems including SAP, TrackWise, electronic batch records, and document management platforms
- Strong understanding of bioprocessing unit operations
- Effective communication and collaboration across technical and management teams
- Solid organizational, technical writing, and presentation skills
- Basic project management and control charting knowledge
- Ability to lead and contribute to cross-functional teams
Benefits
