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Specialist Manufacturing

hace 2 meses

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo
Summary:

The Manufacturing Operations Specialist will support the execution of manufacturing and quality systems with minimal supervision. Responsibilities include managing non-conformances, process validation, procedures, training, and new product introductions. The Specialist applies process and scientific expertise, compliance knowledge, and analytical skills to ensure efficient manufacturing operations. Additionally, this role may serve as the primary process owner for specific manufacturing systems.

Key Responsibilities:

Applied Process Expertise

  • Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations as the document owner.
  • Assess process performance through floor operations observations and data review, and implement process improvements.
  • Provide troubleshooting support for manufacturing issues.
  • Assist in creating training materials and may provide training on scientific or technical aspects of processes.

Process Monitoring

  • Support the establishment of process monitoring parameters and control limits.
  • Collect and assess process monitoring data and deviations.
  • Provide timely support for the execution of quarterly process monitoring reports.

Non-Conformance and CAPA Management

  • Triage non-conformances within established timeframes.
  • Author investigation reports and execute corrective actions.
  • Manage Non-Conformance (NC) and Corrective and Preventive Action (CAPA) closures within set deadlines.
  • Monitor and communicate trends in incidents and equipment/system root cause analyses.

Process Validation

  • Assist in generating and executing process validation protocols and reports.
  • Support data collection and analysis for process validation.

Regulatory Support

  • Participate in regulatory inspections as needed.

New Product Introductions & Process/Equipment Modifications

  • Participate in the New Product Introduction (NPI) process, ensuring proper documentation, materials, training, and equipment modifications are in place.
  • Assist in prioritizing and implementing process or equipment modification projects.

Change Control

  • Assist in the management of manufacturing change control packages that impact processes.

Projects and Initiatives

  • Participate in special projects or initiatives related to manufacturing operations.

Other duties may be assigned as needed.

Competencies/Skills:

  • Strong technical understanding of bioprocessing unit operations.
  • Skilled in performing GMP production operations.
  • Knowledge of regulatory requirements and experience interacting with regulatory bodies.
  • Proven ability to collaborate and communicate with cross-functional teams, including technical and management staff from manufacturing, process development, and quality departments.
  • Strong organizational, technical writing, and presentation skills.
  • Basic project management skills.
  • Knowledge of control charting and data analysis.

Requirements

Required Qualifications:
  • Doctorate degree OR
  • Master’s degree with 3 years of Manufacturing Operations experience OR
  • Bachelor’s degree with 5 years of Manufacturing Operations experience OR
  • Associate’s degree with 10 years of Manufacturing Operations experience OR
  • High school diploma/GED with 12 years of Manufacturing Operations experience.
Preferred Qualifications:
  • Experience leading cross-functional teams and initiatives in a manufacturing environment.
  • Ability to support and manage multiple projects simultaneously.