3–5 years of experience in an engineering role, preferably in process validation, manufacturing, or process engineering.
Bachelor's degree (B.S.) in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biomedical Engineering.
Hands-on experience with process validations, including developing and writing validation protocols and related documentation.
Ability to execute project deliverables according to established schedules and timelines.
Demonstrated capability to work effectively within a team environment and build strong relationships with cross-functional partners such as R&D;, Quality, Manufacturing, and Regulatory.
Strong verbal and written communication skills, with the ability to clearly communicate to individuals at various levels within the organization.
Experience with common problem-solving methodologies, including issue resolution, root cause investigations, and CAPA development and implementation.
Technical writing skills for creating and revising batch records, standard operating procedures, and other technical documents.
Proficiency in Microsoft Word, Excel, and PowerPoint for documentation, data analysis, and presentations.
Experience in manufacturing process support and process optimization activities.
Background in manufacturing line support, helping maintain and improve production processes.