TSMS Operations Engineer, 3rd shift
About The Position
The Manufacturing Science and Technology Engineer will be responsible for supporting all facets of tech transfer, process validation, GMP floor support, and continued process verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the business to ensure robust and reliable production processes are established. The MSAT Engineer is responsible for scaling up and transferring processes into full scale manufacturing process based on data generated internally or received from the client. This is a 3rd shift position.
Requirements
- Bachelor’s degree in science or engineering
- 2+ years in Technical Transfer for pharmaceutical or similar industry
- 2+ years GMP experience
- 1+ year in client-facing role
Nice To Haves
- Master’s degree preferred
Responsibilities
- Develop technical documentation such as Process FMEA, Process Flow Diagrams, and Tech Transfer Plans
- Select appropriate equipment and single-use components for GMP manufacturing
- Recognized as Subject Matter Expert for manufacturing processes in project teams
- Author GMP manufacturing documentation including Master Batch Records, BOM, and Processing Forms
- Monitor process data, identifying trends and proposing actions
- Lead technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventative actions
- Provide technical guidance and oversight to Operations and Validation group to support process performance qualification and continuous process verification
- Assess the impact of changes to the product, process, equipment, procedures, and/or materials
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
