Principal Process Scientist

QRC Group, LLC • Manati, PR

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About The Position

We are seeking a temporary technical resource to provide specialized support to our Sterile Manufacturing Operations. The role requires expertise in process science and parenteral inspection technologies, supporting ongoing operations, technology transfers, and continuous improvement initiatives.

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 (SME) for sterile manufacturing processes, including liquid and lyophilized parenteral products
• Support daily manufacturing operations
• Perform troubleshooting and investigations (e.g., deviations and CAPAs)
• Support process validation activities
• Contribute to technology transfer efforts
• Drive process optimization initiatives
• Ensure compliance with cGMP regulations and site procedures
• Work cross-functionally with manufacturing, engineering, quality, and validation teams
• Ensure alignment with site priorities and regulatory requirements

What This Job Offers

• Career Level: Senior