Merck & Co. is seeking a Deviation Management Contractor to join the Technical Operations Deviation Management team within the Manufacturing Division at our West Point, PA site. This role provides technical support to vaccine manufacturing, focusing on deviation investigations, root cause analysis, corrective/preventative action development, and equipment/process troubleshooting. The position offers an opportunity to build expertise in product and process knowledge while supporting critical GMP operations.
Responsibilities
• Lead and/or support deviation investigations to identify root cause, corrective/preventative actions, event scope, and product impact assessment.
• Analyze issues from multiple perspectives (safety, compliance, automation, equipment, process, and people) to determine effective solutions.
• Support or execute continuous improvement initiatives that increase compliance, streamline processes, and improve efficiency.
• Manage investigation timelines, ensuring compliance and customer due dates are achieved; escalate and remediate potential delays.
• Ensure consistent application of standardized work, engineering practices, and process tools.
• Provide technical support to the manufacturing shop floor, troubleshooting equipment and process issues.
• Conduct experimental protocols as needed using Technical Operations lab facilities and/or full-scale production equipment.
• Author and update technical and manufacturing documents including investigations, protocols, reports, engineering studies, process demonstrations, change control, and validation.
Education
• B.S. degree in Engineering or Sciences.
Experience
• Required:
– Minimum 1 year post-bachelor’s degree experience in GMP manufacturing or GMP technical support (or M.S. degree with <1 year of experience).
– Proven ability to drive results and meet deadlines.
– Strong communication, collaboration, and accountability skills.
– Strong problem-solving abilities.
• Preferred:
– Experience in vaccine manufacturing or sterile processing.
– Technical writing (investigations, protocols, reports).
– Use of investigative tools such as 5-Whys and fishbone analysis.
– Experience authoring investigations for atypical events in a manufacturing environment.
