Process Engineer II, Process Development

Process Engineer II, Process Development - Boca Raton, FL Position Summary The Process Engineer II provides process development and transfer expertise for IgG Immunotherapy Production. Provides updates to PD Management team on a regular basis to ensure compliance issues are met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model. As a key member of the PD group, supports Manufacturing, QC/QA, and Regulatory departments. Essential Functions and Responsibilities Provide support for technical issues related to the manufacturing process and product quality. Develop new processes for production of plasma-derived therapies. Be familiar with regulatory guidelines regarding process development/validation and implementing manufacturing process changes. Optimize and maintain compliance in PD laboratory by ensuring equipment calibration, IQ/OQ/PM status are current. Design and plan scientific experiments to achieve corporate goals for existing projects. Write protocols and reports in support of PD studies. Review and/or approve cGMP documentation generated by other PD group members as necessary. Lead execution of process development/evaluation studies and process validations using a qualified scale down model. Be responsible for transferring process changes and/or new processes from PD to Manufacturing. Act as liaison between PD and Manufacturing for supporting deviations and investigations and for transferring new or optimized processes. Maintain and review process development batch records for scale down process models. Perform other activities as assigned by the PD Managers. Support Manufacturing, Engineering, and Quality Management departments with development and implementation of new process/technology. Assist manufacturing personnel in the execution of process development and process validation studies in a cGMP production environment as needed. Job Competencies Ability to follow cGMPs and procedures with great attention to detail. Ability to work in a high-pressure, deadline-driven environment. Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines. Manage time and balance multiple assignments. Excellent oral and written communication skills with close attention to detail and accuracy. Education Requirements Bachelor’s degree in Science or Engineering required. Experience Requirements Minimum of five (5) years in a cGMP, pharmaceutical/biological manufacturing environment required. Familiarity with aspects of process development. Knowledge of FDA cGMP requirements. Preferred Experience Preferred experience in process validation, scale-down models, and transfer. Benefits 401K plan with employer match and immediate vesting. Medical, Vision, Life and Dental Insurance. Pet Insurance. Company-paid STD and LTD. Company-paid holidays. 3 weeks paid time off (within the first year). Tuition assistance (after the first year). Convenient location near Tri-Rail. Free shuttle to the Boca Tri-Rail station. ADMA Biologics uses E-Verify to confirm employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit https://www.dhs.gov/E-Verify. ADMA Biologics is an Equal Opportunity Employer. #J-18808-Ljbffr