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Manufacturing Specialist 33080 - 1837105

🌟 Job Opportunity: Specialist Manufacturing 33080 🌐

📍 Location: Juncos, PR (Onshore, 100% Onsite work, 8-hour administrative shifts) 🌅

📑 Period: Approximately One Year by contract.

👩‍🎓👨‍🎓 Educational/Software Requirements:

  • Doctorate degree OR
  • Master's degree and 3 years of Manufacturing Operations experience OR
  • Bachelor's degree and 5 years of Manufacturing Operations experience OR
  • Associate’s degree and 10 years of Manufacturing Operations experience OR
  • High school diploma / GED and 12 years of Manufacturing Operations experience.

Preferred Qualifications:

Experience in Manufacturing, Procedures Revision, Change Control, CAPA’s, Investigation process, Deviations, Risk assessment, Problem Solving, Technical Writing, and Process ownership.


With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.


Applied Process Expertise

  1. Initiate, revise, and approve manufacturing procedures. Serve as a document owner. 📑
  2. Assess process performance and implement solutions for process improvement opportunities. 🚀
  3. Provide troubleshooting support. 🔧
  4. Assist in generating training materials. 📚

Process Monitoring

  1. Support establishment of process monitoring parameters and control limits. 📊
  2. Provide support for timely execution of process monitoring reports. 🕒

Non-Conformance and CAPA

  1. Ensure timely triage of Non-conformances. ⏰
  2. Author investigation reports. 📝
  3. Execute corrective actions. ✅
  4. Manage NC/CAPA closure within established goals. 🎯
  5. Monitor and communicate incidents trends. 📈
  6. Review equipment/system Root Cause Analysis investigations. 🔍

Process Validation

  1. Assist in generating process validation protocols and reports. 📑
  2. Assist in the execution of process validation. 🔄
  3. Support collection and analysis of process validation data. 📊


  1. May participate in regulatory inspections. 🕵️‍♂️

New Product Introductions & Process or Equipment Modifications

  1. Participate in the NPI process. 🚀
  2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. 🔄

Change Control

  1. Assist manufacturing change owner on CCRB packages impacting the process. 🔄

Projects and Initiatives

  1. Participate in the assessment or implementation of special projects or initiatives. 🚀


  • Detailed technical understanding of bioprocessing unit operations. 🧪
  • Skilled in GMP production operations. ⚙️
  • Regulatory knowledge. 📚
  • Cross-functional team leadership. 👥
  • Effective communication and collaboration. 🗣️
  • Organizational, technical writing, and presentation skills. 📊
  • Basic project management skills. 🚀
  • Basic knowledge of control charting. 📈

Apply now and be a key player in shaping the future of biotech manufacturing! 🚀🌟

📧 Send your updated resume along with the title Specialist Manufacturing 33080 to 🌐✉️

Thank you. We will be in contact soon.

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