Commissioning/Qualification Specialist / Specific Commissioning and Validation support - Integrated Resources, Inc
Summit, NJ 07901
About the Job
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 Product 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 Client 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.
Additional Job Requirements:
None
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 Product 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 Client 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.
Additional Job Requirements:
None
Source : Integrated Resources, Inc
