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Manufacturing Specialist 33379 - 2389305

Title: Specialist Manufacturing 33379 (Drug Substance and Downstream Process Owners) 🎯💼

Work Type: Hybrid/Virtual/Remote on Administrative Shift 🏠🌐

Location: Puerto Rico (Locals)

Positions: 2 📋


Join our dynamic team as a Specialist Manufacturing 33379! With minimal supervision, you'll support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. Leverage your process, operational, and scientific expertise to enhance manufacturing operations. This role may involve serving as the primary production process owner and assisting with responsibilities on more complex systems.

Preferred Qualifications:

  • Experience in process support, especially on Drug Substance processes, and process-monitoring (collect and analyze data).
  • Knowledge in SAP, TrackWise, electronic batch records, and documents management systems.


Applied Process Expertise

  • ✏️ Initiate, Revise, and Approve Manufacturing Procedures: Ensure all procedures reflect current operations and serve as a document owner.
  • 📊 Assess Process Performance: Evaluate, plan, and implement solutions for process improvement opportunities.
  • 🔧 Provide Troubleshooting Support.
  • 📚 Assist in Generation of Training Materials: May assist in providing training on scientific or technical aspects of the process.

Process Monitoring

  • 🔍 Support Establishment of Process Monitoring Parameters and Control Limits: Collect data and support the assessment of deviations.
  • 🕒 Provide Support for Timely Execution of Process Monitoring Quarterly Reports.

Non-Conformance and CAPA

  • 🚨 Ensure Timely Triage of Non-conformances.
  • 📝 Author Investigation Reports.
  • ✅ Execute Corrective Actions and Manage NC/CAPA Closure.
  • 📈 Monitor and Communicate Incident Trends.
  • 🔍 Review Equipment/System Root Cause Analysis Investigations and Support Trend Evaluations.

Process Validation

  • 📄 Assist with Generation of Process Validation Protocols and Reports.
  • 🧪 Assist with Execution of Process Validation.
  • 📊 Support Collection and Analysis of Process Validation Data.


  • 🏛️ May Participate in Regulatory Inspections.

New Product Introductions & Process or Equipment Modifications

  • 🚀 Participate in NPI Process: Assess requirements for documentation, materials, training, and equipment modifications.
  • ⚙️ Assess, Prioritize, Justify, and Provide Implementation and Project Management Support for Process or Equipment Modification Projects.

Change Control

  • 🔄 Assist Manufacturing Change Owner on CCRB Packages Impacting the Process.

Projects and Initiatives

  • 🌟 Participate in the Assessment or Implementation of Special Projects or Initiatives.

🔍Other functions may be assigned 🔍


  • 🎓 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.


  • 🧬 Detailed Technical Understanding of Bioprocessing Unit Operations.
  • 🏭 Skilled in Performance of GMP Production Operations.
  • 🏛️ Regulatory Knowledge and Interactions.
  • 🤝 Participate and Help Lead Cross-Functional Teams.
  • 💬 Ability to Communicate and Collaborate with Technical and Management Staff within Manufacturing, Process Development, and Quality.
  • 🗂️ Organizational, Technical Writing, and Presentation Skills.
  • Basic Project Management Skills.
  • 📊 Basic Knowledge of Control Charting.

We are excited to find passionate and skilled professionals to join our team! If this opportunity resonates with you, please send your updated resume to with the subject line "Specialist Manufacturing 33379." We look forward to your application! 🌟

Thank you. We will be in contact soon.

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