Engineer - II

Position Title:

Engineer Duration:

12

Months Location:

West Point, PA 19486 Responsibilities Support deviations, including product impact assessments, root cause investigations, and determination of corrective and preventive actions (CAPAs). Assist in writing investigations and quality incident reports. Author, support, update, and/or lead documentation updates, including: SOPs Batch records Change control documents Technical protocols Validation documents Other GMP documentation Support equipment and facility projects for the Sterile Supply areas. Support continuous improvement projects that increase compliance, reduce costs, and simplify or standardize processes. Examine complex issues from diverse perspectives, including safety, compliance, automation, equipment, process, and personnel, to identify and resolve root causes. Design, conduct, review, and approve experimental protocols as needed. Provide on-the-floor support for complex operational and technical process/equipment issues. Complete and/or lead projects focused on: Investigation and execution of CAPAs Improving Right-First-Time performance Preventing and reducing deviations Improving efficiency Reducing costs Increasing compliance Support team safety, environmental, and compliance objectives. Manage project timelines to ensure compliance and customer deadlines are met, escalating risks and developing remediation plans when necessary. Partner effectively with Operations, Quality, Planning, Project Teams, Automation, Maintenance, and external vendors. Education Requirements B.S. or B.A. in Engineering, Sciences, or a related discipline. 2-4 years of experience (combination of co-op and industry experience acceptable). Required Experience & Skills Strong technical writing skills. Highly developed communication, leadership, and teamwork skills. Ability to manage projects and work effectively to schedules and deadlines. Preferred Experience & Skills Deviation management and investigation experience. Experience in biologics, vaccine, or bulk sterile manufacturing facilities. Change control experience. Experience in root cause analysis. Experience in a manufacturing environment. Ability to work in a fast-paced environment and meet aggressive deadlines. SAP and/or Power BI experience is beneficial.