Job Description

Computer Systems Validation Engineer

Summit, NJ (Hybrid Role)

6 months contract

Job Description.

CSV experience, Draft Qualification/validation documents such as Val Plan, IQ/OQ/PQs, RTMs, Summary Reports, Deviations, Test Plans, Worked with change management, cross functional team experience.

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 experience

Working 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.

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