NPI Technical Support Specialist
You will be part of a cross-functional team, providing technical support for new product introduction (NPI) and commercial manufacturing. Your key responsibilities include developing qualification/validation documentation, executing process development studies, and contributing to continuous improvement initiatives.
Key qualifications for this role include a bachelor's degree in science, engineering, or a related field, with 3+ years of experience in GMP settings. Proficiency in equipment and process validation, sterile filling processes, and automation systems is highly desirable.
You will also be responsible for ensuring adherence to global policies, procedures, and guidelines, as well as regulatory requirements and current Good Manufacturing Practices (cGMP). This involves staying up-to-date on industry developments and implementing best practices to enhance operational efficiency.
The ideal candidate will possess strong analytical and problem-solving skills, with the ability to work effectively in a team environment. They should be able to communicate complex technical information clearly and concisely, both verbally and in writing.