One of our large pharmaceutical clients is actively hiring for a Technical Transfer Project Engineer, specializing in sterile filling, supporting the external manufacturing team. This person will be supporting tech transfers for vaccine and biologic drug products and traveling about 6-12 times a year to CMOS across the East Coast & Midwest.
The client is executing sterile drug product technical transfers and would need a Project/Process Engineer to support the program by authoring technical documentation and supporting technical development studies through protocol development, floor execution, sample submission, data analysis, and reporting. As needed, support may be required for routine commercial drug product production (change controls, data analysis, etc.).
This candidate will take process designs, author protocols, and execute different studies at commercial scale. These studies may include but are not limited to mixing studies, fill line studies, engineering batches, etc. You will be hands on with manufacturing of filled vials or syringes and submitting product samples to labs for analysis. The Engineer will also help with data analysis and author reports based off their findings. The client currently uses Microsoft Office-based software and statistical analysis programs (JMP).
You will be integrated into the project teams and involved in the transfer of sterile drug products for commercialization - such as manufacturing drugs at a larger scale, stability testing, drug development, and transfer into their final primary containers, such as vials or syringes, under controlled aseptic conditions.
This is a fully remote position in EST, 25% travel
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5+ years' experience in pharmaceutical manufacturing
B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering.
Involvement in sterile drug product technical transfers
Commercial manufacturing of sterile drug products
Experience in Sterile Manufacturing, STRONG preference in sterile filling (also called Aseptic)
Technical Writing & Change Control
25% travel
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.