Job Description

Job Title: Commissioning/Qualification Specialist

Location: Summit, NJ, 07901

Duration: 06 Month's Contract on W2

Minimum 50% onsite required

work schedule- Normal Business hours

Must Haves:

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, and 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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