Validation Engineer

Job Description

Essential Functions:

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.• Support Lifecycle Document Management System• Develops protocols, and associated reports while adhering to a change management process.• Supports the execution of equipment qualifications and validation protocols• Supervises vendors for qualification functions.• Configures and documents the configuration of computerized systems• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports.• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems• Provides excellent customer service and support.• Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.• Maintains a positive relationship with all team members and site customers while promoting a positive team environment

Required Competencies-Knowledge, Skills, and Abilities:• Strong critical thinking skills.• Ability to learn and function in a fast paced environment• Experience executing qualification documents• Ability to interact effectively with laboratory, QA, and Facilities groups• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Competencies:• Technical / Professional Knowledge• Problem Solving / Troubleshooting• Action Oriented• Attention to Detail• Multi-tasking• Building Relationships

Education & Experience:• BS degree in Engineering / Computer Science or equivalent with 2 years of experience OR• Associate degree with at least 4 years of relevant experienceWorking Conditions:• Environment may include working in office or in a laboratory / manufacturing area.• Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.• Ability to work safely when working alone, or working with others.No Travel required.