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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 and biologic drug products and traveling 3 times per week to a CMO on the west coast.

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 role is 75% travel so ideally looking for local candidates.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

3-4 years' experience in pharmaceutical manufacturing

Involvement in sterile drug product technical transfers

Experience in Sterile Manufacturing, STRONG preference in sterile filling (also called Aseptic)

Technical Writing & Change Control null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].