Specific Commissioning and Validation support-HYBRID

3 weeks ago

Summit, United States Fortira Inc Full time
*Position Details:*

*Job Title:* *Specific Commissioning and Validation support*

*Location: 556 Morris Avenue, Summit, NJ, 07901*

*Duration: 12 Months*

*Job Description*

*Minimum 50% onsite required*

*work schedule- Normal Business hours*

*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.
* Develops written procedures for calibration and preventive maintenance of equipment
* Supports calibration, equipment qualification and validation activities.
* Configures and documents the configuration of computerized systems
* Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
* Manages projects of varying scope and complexity.
* 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
* Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
* Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
* Provides excellent customer service and support.
* Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
* Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
* 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

*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.

The pay rate is “determined/ aware” by client

"IND1"

Job Type: Contract

Pay: $40.00 - $45.00 per hour

Education:
* Bachelor's (Preferred)

Experience:
* QA: 3 years (Preferred)
* Microsoft Office Suite: 1 year (Preferred)

Ability to Commute:
* Summit, NJ 07901 (Preferred)

Work Location: In person

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