Quality Engineer

Location

West Point, PA 19486 USA

44.00/hour

• B.S. or B.A. in Engineering, Sciences, or a related discipline
• 2–4 years of experience (combination of co‑op and industry experience accepted)

• Strong technical writing skills
• Excellent communication, leadership, and teamwork skills
• Ability to manage projects and meet schedules/deadlines

• Deviation management and investigations
• 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 tight deadlines
• SAP and/or Power BI experience is beneficial

• Support deviations, including assessment of product impact, determination of root cause, and development of corrective/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, and 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 that increase compliance, reduce costs, and simplify/standardize processes
• Examine complex issues from multiple perspectives (safety, compliance, automation, equipment, process, and people) to determine 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 to improve process performance, including investigation and execution of CAPAs, Right‑First‑Time initiatives, deviation reduction efforts, efficiency improvements, cost reduction projects, and compliance enhancements
• Support team safety, environmental, and compliance objectives
• Manage project timelines to ensure compliance and customer deadlines are met; escape potential delays and develop remediation plans when necessary
• Partner effectively with Operations, Quality, Planning, project teams, and external vendors