Merck
Incoming Material Deviation Management Specialist
The Incoming Material Deviation Management Specialist is responsible for providing engineering/technical support to the Deviation Management Team within Core Site Services organization at West Point, PA site. The specialist is responsible to support Incoming Material Integrated Product Technology area to remain operational, in compliance, continuously improve and innovate. The Specialist: Authors incident and investigation reports for deviations Coordinates and completes Corrective Actions and Preventive Actions (CAPAs) Authors and reviews Incident Trend Reports Supports deviation reduction efforts Supports, executes, and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process. Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause. Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment. Provides on-the-floor support for project implementation and studies, as required Leads or participates in Quality Risk Assessments. Supports regulatory inspections/audits as required Supports team safety, environmental, and compliance objectives. Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible. Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors. Education Minimum Requirement: B.S. or B.A. in Engineering, Sciences, or related discipline Required Experience and Skills: Minimum two (2) years post-bachelor's degree experience in a regulated environment. Experience in deviation management / project support and/or change control and/or bio-pharm equipment and/or equipment/process validation. Highly developed communication, leadership and teamwork skills. Ability to manage projects/work to schedule/deadlines. Preferred Experience and Skills: Experience in biologics, vaccine, or bulk sterile manufacturing facilities and equipment. Deviation Management Change Management Project Management
The Incoming Material Deviation Management Specialist is responsible for providing engineering/technical support to the Deviation Management Team within Core Site Services organization at West Point, PA site. The specialist is responsible to support Incoming Material Integrated Product Technology area to remain operational, in compliance, continuously improve and innovate. The Specialist: Authors incident and investigation reports for deviations Coordinates and completes Corrective Actions and Preventive Actions (CAPAs) Authors and reviews Incident Trend Reports Supports deviation reduction efforts Supports, executes, and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process. Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause. Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment. Provides on-the-floor support for project implementation and studies, as required Leads or participates in Quality Risk Assessments. Supports regulatory inspections/audits as required Supports team safety, environmental, and compliance objectives. Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible. Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors. Education Minimum Requirement: B.S. or B.A. in Engineering, Sciences, or related discipline Required Experience and Skills: Minimum two (2) years post-bachelor's degree experience in a regulated environment. Experience in deviation management / project support and/or change control and/or bio-pharm equipment and/or equipment/process validation. Highly developed communication, leadership and teamwork skills. Ability to manage projects/work to schedule/deadlines. Preferred Experience and Skills: Experience in biologics, vaccine, or bulk sterile manufacturing facilities and equipment. Deviation Management Change Management Project Management