Qualification and Validation Specialist - Katalyst Healthcares & Life Sciences
Summit, NJ 07901
About the Job
Responsibilities:
- 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 Client's 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.
- BS degree in Engineering / Computer Science or equivalent.
- 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.
- Technical / Professional Knowledge.
- Problem Solving / Troubleshooting.
- Action Oriented.
- Attention to Detail.
- Multi-tasking.
- Building Relationships.
- 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.
Source : Katalyst Healthcares & Life Sciences
