Manufacturing Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

1d

About The Position

FITS is seeking a hands-on, floor-facing Manufacturing Specialist to support a leading biotechnology manufacturer. The role serves as a technical partner to manufacturing operations, maintaining current procedures, troubleshooting process issues, leading investigations, supporting process improvements and validation, and helping bring new products to the manufacturing floor. The specialist collaborates with Manufacturing, Process Development, and Quality and may lead cross-functional teams. The shift is administrative, as needed by business.

Requirements

• Doctorate; or a Master’s degree plus at least 2 years of Manufacturing Operations experience; or a Bachelor’s degree plus at least 4 years of Manufacturing Operations experience.
• Bilingual in English and Spanish.
• Knowledge of GMP manufacturing and bioprocessing unit operations.

Nice To Haves

• Complete risk assessments, Change Controls, and CAPAs, and manage CDOCS.
• Participation in assessing or implementing special projects or initiatives.

Responsibilities

• Serve as document owner and keep manufacturing procedures aligned with current operations.
• Observe floor operations and review performance data to plan and implement process improvements.
• Troubleshoot manufacturing processes using technical knowledge of bioprocessing unit operations.
• Create training materials and support training on scientific and technical aspects of the process.
• Help establish process monitoring parameters and control limits, collect monitoring data, and apply control charting.
• Support timely completion of quarterly process monitoring reports.
• Triage non-conformances within established goals, author investigation reports, and execute corrective actions.
• Manage non-conformance and CAPA closure on time, and monitor and communicate incident trends.
• Review equipment and system root cause analysis investigations and support trend evaluations.
• Help generate and execute process validation protocols and reports, and collect and analyze validation data.
• Participate in regulatory inspections.
• Assess, prioritize, and support implementation of process or equipment modification projects.
• Serve as primary process owner for process support systems and support ownership of more complex systems.
• Collaborate with Manufacturing, Process Development, and Quality, and help lead cross-functional teams.
• Use quality and manufacturing systems such as TrackWise, Veeva, SAP, and MES platforms.

Benefits

• Opportunities to grow a career across FITS’ network of clients in pharma, biotech, and medical devices.
• Opportunity to work on high-impact projects with a leading biotechnology manufacturer in Puerto Rico.

What This Job Offers

• Job Type: Full-time
• Education Level: Ph.D. or professional degree