Job TitleKey Responsibilities Draft, schedule and execute engineering studies/validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines. Coordinates and communicates all testing with affected functional groups and evaluates test results. Execute engineering activities to include, but not limited to: Change Control initiation, protocol preparation, periodic reviews, routine requalification, scheduling, protocol execution, data review and final report generation. Participate and/or present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary. Participates on teams assembled to specify, install, validate, troubleshoot and maintain processes, systems and equipment. Develop and qualify production recipes for manufacturing processes. Review and approve Manufacturing and Packaging records to ensure that the information and documentation conform to company policy and cGMP's. Create, review and approve deviations. Help to define appropriate action plans for improvement and follow-up and communicate action closures. Coordinates all work on scheduled projects needed to meet the deadlines developed by Plant Capital Plan, New Product Introductions, and New Process Technology Developments. Responsible for manufacturing engineering support, the development of new process technologies, and the support of new product introductions/tech transfers. Organizes testing associated with the development of new process technologies and the support of new product introductions/tech transfers. Works closely with site tech. services to develop and confirm Critical Process Parameters needed for Equipment and processes. Develops and delivers presentations to communicate project timelines and milestone completions. Design technical/engineering studies, writes technical reports summarizing study results and generates necessary data to support process development for new equipment, process changes, commodity changes and/or investigation/CAPA support. Generate/Support site technical assessments (i.e., alarm, risk, engineering).Role Requirements/Qualifications Applicant must have a HS Diploma (or Equivalent) and 6 years of relevant experience OR an associate's degree with 4 years of experience OR a bachelor's degree with 0+ years of experience Excellent attention to detail Excellent organizational skills, and ability to handle changing deadlines Strong communication with written and verbal skills Working knowledge of Microsoft Office, especially Excel for evaluation of data Nice-to-have/Preferred Technical writing experience. Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices. Working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices. Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
