Job title: Commissioning/Qualification
Company: Katalyst HealthCares & Life Sciences
Job description: 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.
- 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.
Requirements:
- BS degree in Engineering / Computer Science or equivalent with 2 years of experience OR.
- Associate degree with at least 4 years of relevant experience.
- 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.
- 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.
Competencies:
- Technical / Professional Knowledge.
- Problem Solving / Troubleshooting.
- Action Oriented.
- Attention to Detail.
- Multi-tasking.
- Building Relationships.
Expected salary:
Location: Summit, NJ
Job date: Thu, 22 May 2025 07:01:42 GMT
Apply for the job now!