Requirements

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  A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred. Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or Master's degree with 3+ years of relevant scientific experience; or Bachelor's degree with 5+ years of relevant scientific experience.
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  Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.
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  Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
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  Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
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  Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
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  Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
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  Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
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  Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
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  Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
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  Strong technical writing, communication, presentation, and project management skills.
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  Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
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  Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable
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  Fully Bilingual (English and Spanish)