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Specialist Manufacturing - 33296

🌟 Specialist Manufacturing (Pharmaceutical/Biotech Industry) 🌟

📍 Location: 100% onsite

Shift: Administrative shift (8:00 AM to 5:00 PM)

🔢 Positions Available: 1️⃣


With minimal supervision, support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Serve as the primary production process owner for support systems and assist with complex process systems.

Educational/Software Requirements:

🎓 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:

  • Strong knowledge of parenteral drug product inspection, labeling, and packaging
  • Expertise in change control processes, owning Change Control, and ensuring timely implementation
  • Experience in decommissioning facilities
  • Ability to participate in and help lead cross-functional teams
  • Project management skills
  • Ability to handle multiple priorities within short timeframes with high quality


Applied Process Expertise:

🔧 Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations. Serve as a document owner

🔧 Assess process performance by observing floor operations and reviewing performance data. Plan and implement process improvement solutions

🔧 Provide troubleshooting support

🔧 Assist in creating training materials and potentially provide training on scientific or technical aspects of the process

Process Monitoring:

📊 Support the establishment of process monitoring parameters and control limits. Collect and assess process-monitoring data

📊 Ensure timely execution of process monitoring quarterly reports

Non-Conformance and CAPA:

🚨 Ensure non-conformances are triaged within the established goal

🚨 Author investigation reports and execute corrective actions

🚨 Manage NC/CAPA closure within established goals and monitor incident trends

🚨 Review Root Cause Analysis investigations for equipment/systems and support trend evaluations

Process Validation:

✅ Assist in generating and executing process validation protocols and reports

✅ Support the collection and analysis of process validation data


📜 May participate in regulatory inspections

New Product Introductions & Process or Equipment Modifications:

🔄 Participate in NPI processes to assess documentation, materials, training, and equipment modification requirements

🔄 Provide implementation and project management support for process or equipment modification projects

Change Control:

📝 Assist manufacturing change owners on CCRB packages impacting the process

Projects and Initiatives:

📌 Participate in the assessment or implementation of special projects or initiatives


  • In-depth technical understanding of bioprocessing unit operations
  • Skilled in GMP production operations
  • Regulatory knowledge and experience
  • Effective communication and collaboration with technical and management staff
  • Strong organizational, technical writing, and presentation skills
  • Basic project management skills
  • Basic knowledge of control charting

Join our team and make a significant impact on the pharmaceutical and biotech industry! 🚀 Apply now by sending your updated resume to with "Specialist Manufacturing 33296" in the subject line. We look forward to welcoming you and achieving success together! 🌟

Thank you. We will be in contact soon.

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