TSMS Engineer
About The Position
The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer supports technology transfer, process validation, GMP floor support, and continued process verification for clinical and commercial programs in accordance with current good manufacturing practices (cGMP). The role provides technical oversight to production to help establish robust and reliable manufacturing processes. The engineer scales up and transfers processes into full-scale manufacturing, using data generated internally or received from clients. The role selects suitable equipment and single-use components, develops technical documentation, authors GMP manufacturing documents, and provides technical guidance to Operations and Validation. It also represents TSMS on project teams, communicates with customers, monitors process data, leads troubleshooting and investigations, assesses change impacts, and coordinates critical-path tasks to meet deadlines.
Requirements
- Bachelor’s degree in Science or Engineering.
- 1–3 years of GMP experience.
- Experience in technology transfer in the pharmaceutical or a related industry.
Nice To Haves
- Master’s degree in Science or Engineering.
Responsibilities
- Autonomously scale up and transfer processes into full-scale manufacturing based on internally generated or client-provided data.
- Select appropriate equipment and single-use components for GMP manufacturing.
- Develop technical documentation, including Technology Transfer Plans, gap assessments, process flow diagrams, summary reports, and Process FMEAs.
- Represent TSMS in project teams and communicate directly with customers as a subject matter expert for manufacturing processes.
- Author GMP manufacturing documentation, including Master Batch Records, Bills of Materials, and Processing Forms.
- Monitor process data, identify trends, and propose actions as necessary.
- Lead technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment, and effective corrective and preventive actions.
- Provide technical guidance and oversight to Operations and Validation to support Process Performance Qualification and Continuous Process Verification.
- Collaborate with cross-functional teams to assess and implement new technology for GMP manufacturing.
- Assess the impact of changes to products, processes, equipment, procedures, and materials.
- Manage timelines and prioritize critical-path tasks to meet deadlines.
- Perform other responsibilities as required.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
