Dry-EM Scientist: Spray Dry, Tech Transfer & Validation

Pinnaql, Inc.; Barceloneta (PR); On-site; USD 110,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking an experienced TS/MS Scientist for Dry External Manufacturing to lead spray dry and solid dosage processes, support technology transfer, and ensure regulatory-compliant manufacturing across external partners.

The role requires strong scientific leadership, documentation capabilities, and collaboration with disparate teams to resolve issues and drive continuous improvements in a GMP environment.

Qualifications

• Bachelor's degree (minimum) in Chemistry, Pharmacy, or Engineering.
• 5+ years of hands-on spray dry and solid dosage manufacturing experience.
• Knowledge of cGMPs and global regulatory guidance.
• Strong regulatory and quality systems understanding.

Responsibilities

• Provide technical oversight for spray dry and solid dosage manufacturing.
• Resolve technical issues related to control strategy and manufacturing.
• Author deviations and change controls with strong writing skills.
• Support CAPA closure with timely investigations.
• Coordinate with internal and external partners and cross-functional teams.
• Ensure compliant, validated manufacturing processes.
• Support external manufacturers during transfer and validation activities.
• Operate in 24/7 environments across time zones.

Skills

Spray Dry

Solid Dosage

Regulatory Knowledge

Data Management

Project Management

Cross-functional Collaboration

Technical Writing

CAPA Investigations

Communication Skills

SAP Experience

Statistical Analysis

FDA Regulated Manufacturing

Education

Bachelor's degree in Chemistry, Pharmacy, or Engineering

Tools

SAP

Job description

Validation & Engineering Group, Inc. is seeking an experienced TS/MS Scientist for Dry External Manufacturing to lead spray dry and solid dosage processes, support technology transfer, and ensure regulatory-compliant manufacturing across external partners.

The role requires strong scientific leadership, documentation capabilities, and collaboration with disparate teams to resolve issues and drive continuous improvements in a GMP environment.