Specialist Manufacturing

Responsibilities

• Initiate, revise, review, and approve manufacturing procedures and SOPs
• Evaluate manufacturing processes through floor observations and performance metrics
• Identify and implement process improvements to enhance efficiency and compliance
• Provide technical troubleshooting support for manufacturing operations
• Support the implementation of new manufacturing processes and equipment modifications
• Collect, analyze, and interpret process monitoring data
• Support the preparation, execution, and documentation of process validation activities
• Conduct deviation assessments and author investigation reports
• Execute and monitor Corrective and Preventive Actions (CAPA)
• Support Change Control activities and documentation updates
• Create training materials and provide training to manufacturing personnel
• Support New Product Introductions (NPI) by coordinating documentation and equipment readiness

Requirements

• Doctorate, OR
• Master's degree with 2+ years of Manufacturing Operations experience, OR
• Bachelor's degree with 4+ years of Manufacturing Operations experience, OR
• Associate degree with 8+ years of Manufacturing Operations experience, OR
• High School Diploma/GED with 10+ years of Manufacturing Operations experience
• Strong knowledge of GMP manufacturing operations and quality systems
• Understanding of bioprocessing or manufacturing unit operations
• Strong technical writing and documentation abilities

Preferred Qualifications

• Experience in biotechnology or pharmaceutical regulated manufacturing environments
• Hands-on experience with Deviations, CAPA, and Change Control
• Experience using quality and manufacturing systems such as SAP, TrackWise, PAS/X, or Veeva

About the Company

BioPharma Consulting JAD Group provides specialized expertise in the biopharmaceutical industry.