Engineer - II (Associate)

Position Title:

Engineer II (Associate)

Duration:

12

Months Location:

West Point, PA 19486 Key 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 Incoming Materials, Supplies Inspection, Culture Media, Weigh and Dispense Operations, and Black Widow Spider areas. Support continuous improvement projects aimed at increasing compliance, reducing costs, and simplifying or standardizing processes. Analyze complex issues from multiple perspectives, including safety, compliance, automation, equipment, process, and personnel, to identify and resolve root causes. Design, conduct, review, and approve experimental protocols as required. Provide on-the-floor support for complex operational and technical process/equipment issues. Lead or support projects focused on: CAPA execution and effectiveness Improving Right-First-Time performance Preventing and reducing deviations Improving operational 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, 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. Root cause analysis experience. Manufacturing environment experience. Ability to work in a fast-paced environment and meet aggressive deadlines. SAP and/or Power BI experience is beneficial.