MS&T Engineer I/II

About This Role

This role will provide on-site technical support for clinical and commercial non-sterile drug product manufacturing, focusing on tech transfers, process validation, and troubleshooting to ensure compliance with cGMP and regulatory requirements.

Responsibilities

• Provide technical assistance for tech transfers and validation efforts for assigned manufacturing projects
• Write Master Batch Records with an understanding of equipment, critical process parameters, and in-process tests
• Monitor manufacturing processes during production runs to assess technical process issues and provide troubleshooting support
• Author manufacturing investigations and complete CAPA assignments
• Compose process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols
• Identify specific parameters, sampling, and tests used in the validation protocols of new and existing products
• Interact with clients during routinely scheduled project meetings
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements

Requirements

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field
• Minimum 4-6 years of experience of technical support and technical transfer in a non-sterile pharmaceutical manufacturing environment
• Working knowledge of cGMP requirements related to non-sterile drug product manufacturing processes
• Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field
• Minimum 4-6 years of experience of technical support and technical transfer in a non-sterile pharmaceutical manufacturing environment

Nice to Have

• Working knowledge of US/EU regulations

Benefits