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.
Job Tags
Contract work, For contractors, Work alone,