Specialist Manufacturing

hace 3 semanas

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Job Summary:
The Specialist Manufacturing provides technical and operational expertise to support manufacturing and quality systems. This role works independently with minimal supervision to support key manufacturing activities such as non-conformance handling, process validation, training, and new product introductions. The specialist will also serve as a primary process owner for support systems and contribute to process ownership on more complex systems.

Key Responsibilities:

  • Applied Process Expertise:
    • Develop, update, and approve manufacturing procedures; ensure alignment with current operations as document owner.
    • Assess floor operations and performance data to identify and implement process improvement opportunities.
    • Troubleshoot production issues and assist with developing training materials for technical aspects of the process.
  • Process Monitoring:
    • Establish and support monitoring parameters and control limits for process control.
    • Gather and analyze process data and support quarterly process monitoring reports.
  • Non-Conformance and CAPA:
    • Ensure timely triage of non-conformances and author investigation reports.
    • Execute corrective actions, manage NC/CAPA closure within established timelines, and monitor incident trends.
    • Support equipment/system Root Cause Analysis investigations and trend evaluations.
  • Process Validation:
    • Assist with process validation protocol generation, execution, and data collection.
    • Support process validation data analysis and report generation.
  • Regulatory:
    • Participate in regulatory inspections, as needed.
  • New Product Introductions & Equipment Modifications:
    • Engage in the New Product Introduction (NPI) process to document requirements, manage materials, and assess training/equipment modifications.
    • Provide project management support for process or equipment modifications.
  • Change Control:
    • Assist with CCRB packages impacting the process.
  • Projects and Initiatives:
    • Participate in assessments and implementation of special projects or initiatives.

Skills:

  • Strong technical understanding of bioprocessing and GMP production.
  • Regulatory knowledge and ability to interact with regulatory bodies.
  • Organizational and project management skills.
  • Ability to lead cross-functional teams and collaborate with diverse groups across manufacturing, quality, and process development.
  • Technical writing skills and a working knowledge of control charting.

Requirements

Education Requirements:

  • Doctorate in a relevant field, OR
  • Master’s degree with 3+ years of Manufacturing Operations experience, OR
  • Bachelor’s degree with 5+ years of Manufacturing Operations experience, OR
  • Associate degree with 10+ years of Manufacturing Operations experience, OR
  • High school diploma/GED with 12+ years of Manufacturing Operations experience.

Preferred Qualifications:

  • Background in Quality or Engineering.
  • Project management experience, with a demonstrated ability to lead cross-functional teams.
  • Experience with quality management systems (e.g., TrackWise, Veeva Systems) for handling Deviations, CAPAs, and Change Controls.
  • Proficient in SAP or similar ERP systems.
  • Excellent communication, technical writing, and presentation skills.
  • Ability to work autonomously, manage competing priorities, and present data logically.
  • Demonstrated ability to apply structured problem-solving and maintain productive remote relationships with team members.

Shift:

  • 8-hour shifts | 8:00 am – 5:00 pm, 5 days a week

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