Specialist Manufacturing Job at BioPharma Consulting JAD Group in Juncos

Overview

The role applies process, operational, and scientific expertise, along with compliance knowledge, analytical, and troubleshooting skills to support manufacturing operations. This position may serve as the primary production process owner for process support systems and assist with ownership responsibilities for more complex systems.

Key Responsibilities

• Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations.
• Act as document owner for assigned procedures.
• Assess process performance by observing floor operations and reviewing performance data.
• Identify, evaluate, and implement solutions for process improvements.
• Provide troubleshooting support.
• Assist with generating training materials and may deliver training on scientific/technical aspects of processes.
• Support establishment of process monitoring parameters and control limits.
• Collect and analyze process-monitoring data.
• Support timely execution of quarterly process monitoring reports.
• Triage non-conformances within established timelines.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure to meet goals and monitor incident trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with development of validation protocols and reports.
• Support execution of process validation activities.
• Collect and analyze process validation data.
• Participate in regulatory inspections as needed.
• Support New Product Introductions (NPI) by assessing documentation, training, materials, and equipment modification requirements.
• Assess, prioritize, justify, and implement process/equipment modification projects.
• Support manufacturing change owners in preparing CCRB packages impacting processes.
• Participate in assessments and implementation of special projects or initiatives.
• Perform other functions as assigned.

Competencies & Skills

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Knowledge of regulatory compliance and inspection readiness.
• Ability to work on and help lead cross-functional teams.
• Strong communication and collaboration skills with technical and management staff across manufacturing, quality, and process development.
• Strong organizational, technical writing, and presentation skills.
• Basic project management capabilities.
• Familiarity with control charting and data-driven process monitoring.

Education & Experience Requirements

• Doctorate OR
• Master’s degree + 2 years of Manufacturing Operations experience OR
• Bachelor’s degree + 4 years of Manufacturing Operations experience OR
• Associate’s degree + 8 years of Manufacturing Operations experience OR
• High School Diploma/GED + 10 years of Manufacturing Operations experience.

Preferred Qualifications

• Experience in process support for Drug Substance processes and process monitoring (data collection and analysis).
• Proficiency with SAP, TrackWise, electronic batch records, and document management systems.

Work Schedule

• Administrative Shift with flexibility to support operational needs.