Biopharma Manufacturing & Process Improvement Specialist

Frey Consulting Group; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Frey Consulting Group seeks a Specialist Manufacturing to support biopharmaceutical operations in a highly regulated environment in Juncos, Puerto Rico. You will assist with manufacturing processes, quality systems, process validation, CAPAs, deviations, and NPI as process owner for assigned systems.

You will apply analytical thinking, problem-solving, and strong communication to drive continuous improvement while complying with cGMP and GDP standards.

Qualifications

• Bachelor's degree in related engineering or life sciences with 4+ years in manufacturing ops (or 2+ years with master's).
• Experience in regulated biopharmaceutical environments (FDA-regulated) is preferred.
• Knowledge of cGMP, GDP, and manufacturing compliance.

Responsibilities

• Author, revise, review, and approve manufacturing procedures.
• Monitor operations via floor observations and data analysis.
• Support NC/CAPA management and investigations.
• Assist in process validation, NPI, and regulatory compliance.
• Support Change Control documentation and CCRB packages.
• Contribute to continuous improvement initiatives.

Skills

Manufacturing Operations

Process Engineering

Process Validation

Change Control

CAPA

Root Cause Analysis

cGMP

GDP

Quality Systems

Lean / Continuous Improvement

Analytical Troubleshooting

Cross-functional Collaboration

Documentation

Communication Skills

Problem Solving

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biotechnology

Other Engineering or Life Sciences

Job description

Frey Consulting Group seeks a Specialist Manufacturing to support biopharmaceutical operations in a highly regulated environment in Juncos, Puerto Rico. You will assist with manufacturing processes, quality systems, process validation, CAPAs, deviations, and NPI as process owner for assigned systems.

You will apply analytical thinking, problem-solving, and strong communication to drive continuous improvement while complying with cGMP and GDP standards.