Specialist Manufacturing

hace 1 semana

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Summary:

The Manufacturing Operations Specialist will support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role requires applying process, operational, and scientific expertise, basic compliance knowledge, and strong analytical and troubleshooting skills to enhance manufacturing operations. The candidate will also serve as the primary production process owner for process support systems and may assist with process ownership for more complex systems.

Key Responsibilities:

  • Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations. Serve as the document owner for these procedures.
  • Assess process performance through floor observation and performance data review. Implement solutions to improve processes.
  • Provide troubleshooting support for manufacturing processes.
  • Assist in the creation of training materials and conduct training on scientific or technical aspects of the manufacturing process.
  • Support the establishment of process monitoring parameters and control limits.
  • Collect and analyze process-monitoring data and assist in assessing deviations.
  • Ensure timely execution of quarterly process monitoring reports.
  • Ensure timely triaging of Non-conformances (NCs) within established goals.
  • Author investigation reports for NCs and execute corrective actions.
  • Manage NC and CAPA closure within established timelines and communicate incident trends.
  • Review equipment/system Root Cause Analysis (RCA) investigations and support trend evaluations.
  • Assist in generating process validation protocols and reports.
  • Support the execution of process validations and the collection/analysis of validation data.
  • May participate in regulatory inspections as required.
  • Participate in NPI processes to assess documentation, material, training, and equipment modification requirements.
  • Provide project management support for implementing process or equipment modifications.
  • Assist manufacturing change owners in managing CCRB packages impacting manufacturing processes.
  • Manage change control records for process-related changes.
  • Contribute to the assessment or implementation of special projects or initiatives.
  • Perform other duties as assigned.

Skills & Competencies:

  • In-depth technical knowledge of bioprocessing unit operations.
  • Experience in GMP production operations and regulatory compliance.
  • Strong ability to participate in and lead cross-functional teams.
  • Excellent communication and collaboration skills with technical and management staff across manufacturing, process development, and quality.
  • Strong organizational, technical writing, and presentation skills.
  • Basic project management capabilities.
  • Understanding of control charting and process monitoring.

Requirements

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 with Change Control, CAPA, VAPA EV, deviations, and documentation handling will make a candidate stand out.

Work Schedule:

  • 8-hour shift, 8:00 AM to 5:00 PM, flexible to work weekends.

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