Senior MSAT Engineer

Job Title:
Senior MSAT Engineer

Job Overview:
The Senior MSAT Engineer will play a key role in supporting technology transfer, process validation, GMP floor support, and continued process verification for clinical and commercial programs. This position provides technical oversight to ensure robust, reliable, and compliant manufacturing processes. The ideal candidate will leverage expertise in scale-up and process transfer to strengthen operations, contribute to cross-functional initiatives, and drive innovation in GMP manufacturing.

Job Responsibilities:

• Select and implement appropriate equipment and single-use components for GMP manufacturing.

• Develop technical documentation such as Tech Transfer Plans, Gap Assessments, Process Flow Diagrams, and Process FMEAs.

• Serve as a subject matter expert for manufacturing processes and represent MSAT on project teams.

• Communicate directly with customers to provide technical updates and expertise.

• Author GMP documentation including Master Batch Records, Bills of Materials, and Processing Forms.

• Monitor process data, identify trends, and recommend corrective actions as needed.

• Lead troubleshooting and investigations of process issues, including root cause analysis and corrective/preventive action planning.

• Provide technical guidance to Operations and Validation teams to support Process Performance Qualification and Continuous Process Verification.

• Collaborate with cross-functional teams to evaluate and implement new manufacturing technologies.

• Assess the impact of changes to products, processes, equipment, procedures, and materials.

Qualifications:

• Bachelor’s degree in science or engineering required.

• 5 or more years of GMP experience within pharmaceutical manufacturing.

• Proven experience with technology transfer in pharmaceutical or related industries.

• Strong knowledge of process validation and manufacturing documentation.

• Demonstrated ability to troubleshoot complex process issues and lead investigations.

• Excellent cross-functional collaboration and communication skills.

• Master’s degree in science or engineering preferred.