Process Engineer - MSAT, GMP, Tech Transfer

Responsibilities

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
• Maintains monitoring of manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
• Completes manufacturing investigations and completes CAPA assignments.
• Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
• Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
• Interacts with clients during routinely scheduled project meetings.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field required.
• Minimum 2 years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment.
• Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required.
• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
• Proficiency with Microsoft office (Word, Excel, Outlook) required.
• Ability to interact with internal stakeholders and external customers.
• Working knowledge of EU regulations is preferred.