Specialist Manufacturing

BioPharma Consulting JAD Group Ver todas las vacantes

Juncos, PR
Autónomo
Tiempo completo

Hace 3 días

Job Description:With minimal supervision, the Manufacturing Specialist supports the execution and continuous improvement of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions (NPI). This role applies process, operational, and scientific expertise along with compliance knowledge to support manufacturing operations, troubleshoot issues, and enhance process performance. The specialist may serve as a process owner for defined systems and support more complex operations.Key Responsibilities

Author, revise, and approve manufacturing procedures; serve as document owner
Ensure procedures accurately reflect current operations and compliance requirements
Monitor and assess process performance through floor observation and data analysis
Identify, plan, and implement process improvements
Provide technical troubleshooting support to manufacturing operations
Develop and support training materials; assist in technical training delivery
Support establishment of process monitoring parameters and control limits
Collect and analyze process monitoring data
Assist in deviation assessment and resolution
Support the preparation and timely execution of quarterly process monitoring reports
Ensure timely triage of non-conformances (NCs)
Author investigation reports and support root cause analysis
Execute and track corrective and preventive actions (CAPAs)
Drive closure of NC/CAPA within established timelines
Monitor and communicate trends in deviations and incidents
Review and support equipment/system root cause investigations
Support development of validation protocols and reports (IQ/OQ/PQ)
Assist in execution of validation activities
Collect, analyze, and summarize validation data
Support regulatory inspections and audit readiness activities
Ensure compliance with cGMP and internal quality standards
Participate in NPI activities, including assessment of documentation, materials, training, and equipment needs
Support implementation of process and equipment modifications
Assist in change control processes (CCRB), including documentation and impact assessment
Participate in cross-functional projects and initiatives
Support implementation of process improvements and operational excellence efforts
Provide basic project management support for manufacturing-related projects

Core Competencies

Technical expertise in manufacturing processes and equipment
Strong troubleshooting and analytical problem-solving skills
Knowledge of regulatory requirements and compliance (cGMP)
Ability to work and collaborate across cross-functional teams
Effective communication with technical and management personnel
Organizational skills and attention to detail
Technical writing and documentation skills
Basic project management capabilities
Knowledge of statistical tools such as control charting

Requirements:Education & Experience

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 with deviation documentation and Change Control Management
Strong knowledge of bioprocessing unit operations
Experience in GMP-regulated manufacturing environments
Familiarity with process validation and quality systems

Benefits:

Administrative shift
6-month contract

BioPharma Consulting JAD Group

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