Commissioning/Qualification
Commissioning/Qualification
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 multiuser 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 fastpaced 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 wellformulated 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.
- Multitasking.
- Building Relationships.
Employment Type
Full Time
