Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support
Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support
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1 Vacancy
Job Description
Job Title: Qualification & Validation Specialist
Location: Summit NJ
Workplace Type: 50% Onsite
Duration: 6 Months w/ potential extension (but not guaranteed)
Job ID: 62260-1
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 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.
No Travel required.
Employment Type
Full Time
