Principal Process Scientist

QRC Group, LLC • Manati, PR

1d

About The Position

We are seeking a Principal Process Scientist will serve as a Subject Matter Expert for sterile manufacturing processes, including liquid and lyophilized parenteral products. This resource will support daily manufacturing operations, troubleshooting, investigations (e.g., deviations and CAPAs), and process validation activities. The role will also contribute to technology transfer efforts, process optimization, and ensuring compliance with cGMP regulations and site procedures.

Requirements

• Strong technical expertise
• Problem-solving capabilities
• Experience in pharmaceutical sterile manufacturing environments
• Bachelor’s degree in Science (Engineering, Chemistry, Microbiology, Biotechnology, or related field)
• Approximately 8–12+ years of experience in sterile pharmaceutical manufacturing, including parenteral processes
• Experience supporting investigations, validations, and technology transfers in a SME capacity

Responsibilities

• Serve as a Subject Matter Expert for sterile manufacturing processes, including liquid and lyophilized parenteral products.
• Support daily manufacturing operations.
• Support troubleshooting.
• Support investigations (e.g., deviations and CAPAs).
• Support process validation activities.
• Contribute to technology transfer efforts.
• Contribute to process optimization.
• Ensure compliance with cGMP regulations and site procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior