Job Description
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 or biologic drug products in Eastern Washington.
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.
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Required Skills & Experience
3-4 years' experience in pharmaceutical manufacturing
B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering.
Lyophilization process development experience
Involvement in sterile drug product technical transfers
Experience in Sterile Manufacturing, STRONG preference in sterile filling
Technical Writing & Change Control
Benefit packages for this role will start on the 1st 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.