Pharma Manufacturing Specialist: NPI & Process Excellence

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

Job summary

ProQuality Network in Juncos, Puerto Rico is seeking a Specialist Manufacturing to support the execution and maintenance of manufacturing and quality systems, including non-conformances, process validation, training, and new product introductions (NPI).

The role requires applying process and operational expertise, scientific knowledge, basic compliance principles, analytical thinking, and troubleshooting skills to support manufacturing operations.

Qualifications

• Doctorate degree required or equivalent.
• Master's degree plus 2 years of Manufacturing Operations experience acceptable.
• Bachelor's degree plus 4 years of Manufacturing Operations experience.
• Associate degree plus 8 years of Manufacturing Operations experience.
• High school diploma or GED plus 10 years of Manufacturing Operations experience.

Responsibilities

• Initiate, revise, and approve manufacturing procedures, serving as document owner when assigned.
• Assess process performance through direct observation and performance data review.
• Provide technical troubleshooting support for manufacturing processes.
• Assist in developing and delivering training on manufacturing processes.
• Support process monitoring parameters and quarterly reports.
• Manage NC and CAPA activities to ensure timely closure.
• Assist with process validation protocols and reports.
• Participate in NPI activities and regulatory inspections as needed.

Skills

Bioprocessing

GMP operations

Regulatory knowledge

Cross-functional teams

Technical writing

Project management basics

SPC knowledge

Education

Doctorate degree

Master's degree + 2 years

Bachelor's degree + 4 years

Associate degree + 8 years

High school diploma + 10 years

Job description

ProQuality Network in Juncos, Puerto Rico is seeking a Specialist Manufacturing to support the execution and maintenance of manufacturing and quality systems, including non-conformances, process validation, training, and new product introductions (NPI).

The role requires applying process and operational expertise, scientific knowledge, basic compliance principles, analytical thinking, and troubleshooting skills to support manufacturing operations.