Biotech Manufacturing Specialist: Process & Quality

ProQuality Network; Caguas (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

ProQuality Network in Puerto Rico is seeking a Specialist Manufacturing Operations in the biotechnology sector to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role requires applying scientific, operational, and compliance expertise to day-to-day manufacturing operations.

The ideal candidate will also assist in troubleshooting, documentation management, and continuous process improvement.

Qualifications

• Master’s degree with 3 years of experience in Manufacturing Operations or
• Bachelor’s degree with 5 years of experience in Manufacturing Operations or
• Associate degree with 10 years of experience or
• High School diploma / GED with 12 years of relevant experience

Responsibilities

• Initiate, revise, and approve manufacturing procedures ensuring alignment with current operations.
• Serve as document owner and maintain up-to-date procedure documentation.
• Evaluate and improve process performance through data analysis and floor observation.
• Provide technical troubleshooting support.
• Assist in developing training materials and support training delivery on technical or scientific topics.
• Support the establishment of process monitoring parameters and control limits.
• Collect process-monitoring data and assist in deviation assessments.
• Contribute to timely execution of quarterly process monitoring reports.
• Ensure non-conformances are triaged and addressed within established timelines.
• Author investigation reports and manage the execution of corrective actions.
• Oversee the closure of non-conformances and CAPAs.
• Monitor trends and provide communication of incident data.
• Review and support root cause analysis investigations and trend assessments.
• Assist in drafting process validation protocols and reports.
• Support the execution of validation protocols.
• Collect and analyze data to support process validation activities.
• May participate in regulatory inspections and ensure compliance with relevant standards.
• Participate in NPI processes by evaluating documentation, materials, training, and equipment requirements.
• Support project management for equipment or process modifications, including prioritization and implementation.
• Assist with change control processes, including supporting the manufacturing change owner on CCRB packages.
• Contribute to the assessment and implementation of special projects or initiatives

Skills

GMP compliance

Cross-functional collaboration

Technical writing

Data analysis

Communication

Education

Master's degree in Manufacturing Operations

Bachelor's degree in related field

Associate degree with 10 years experience

High School diploma / GED with 12 years experience

Job description

ProQuality Network in Puerto Rico is seeking a Specialist Manufacturing Operations in the biotechnology sector to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role requires applying scientific, operational, and compliance expertise to day-to-day manufacturing operations.

The ideal candidate will also assist in troubleshooting, documentation management, and continuous process improvement.