To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Responsibilities: • Designs, monitors, or conducts strategies with general guidance from the supervisor. • Provides data analysis and interpretation and assesses the impact of the data on the project. Keeps current in technical expertise and areas relevant to their function. • Monitors field of expertise, including literature and technology development, and communicates relevant observations. • Develop and implement new and novel protocols to address specific issues. • May represent the department on project teams under the supervision of a senior scientific staff member. • May initiate productive collaborations within and outside of the department or company. • Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. • Able to develop solutions to routine technical problems of limited scope. • Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations. Job Requirements: • Experience in drug product manufacturing. • Process Validation • Writing technical protocols or reports. • Advanced scientific analysis and troubleshooting skills.Advanced laboratory work skills. • Ability to motivate and/or supervise the activities of others. • Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. • Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolution.Analytical problem solvingProject management. • Ability to be flexible and manage change. • Computer literacy (Windows environment: Word, Excel, Power Point). • Skills requiring the application of scientific theory. • Creative skills in the design and performance of scientific experiments and interpretation of results. • Strong knowledge of cGMP • Fully bilingual (English/Spanish). Education: • Doctorate OR Masters + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience. • Preferred: Educational background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).