We have other current jobs related to this field that you can find below
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CSV Engineer
8 hours ago
Summit, United States On-Board Companies Full timeOn-Board Administrative is hiring a CSV Engineer For immediate consideration please send your resume to resumes@onboardusa.com Subject Line: Position Title and State you are Located About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer...
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CSV Engineer
1 month ago
Summit, United States On-Board Companies Full timeOn-Board Administrative is hiring a CSV Engineer For immediate consideration please send your resume to resumes@onboardusa.com Subject Line: Position Title and State you are Located About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer...
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CSV Engineer
6 days ago
Summit, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities & Requirements: Client is looking for a consultant who specializes in MES & LIMS sample management module as well as help with a QMS update. The QMS update has no specific timeline .(done by end of year) Tulip is MES and L7 need to be done by December. This person would have to have regular meetings due to more system owners, a few...
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Summit, United States Artech Full timeTitle: Engineering - Validation Engineer Job Duration: 12+ Months (possible extensions) Job Location: Summit, NJ Job Description: 50% onsite required Work schedule: M-F (Should be flexible on timings based on business needs) Purpose and Scope of Position: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment, and...
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Validation Engineer
10 hours ago
Summit, United States Aequor Technologies Full time50% onsite Bachelor's required Must Haves: Implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites Capable of taking independent ownership of all lifecycle deliverables in the qualification of equipment and full CSV for single and multi-user Computerized Systems. Job Description: The CSV Engineer supports the...
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Validation Engineer
1 month ago
Summit, United States TSR Consulting Full timeAbout TSR: TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely...
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Validation Specialist
1 month ago
Summit, United States TSR Consulting Services, Inc. Full timeTSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a MES Validation Specialist.Job ID #80107 Rate type: W2 only CommentsMinimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager...
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Validation Specialist
1 month ago
Summit, United States Tsr Consulting Services Inc. Full timeTSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a MES Validation Specialist.Job ID #80107 Rate type: W2 only CommentsMinimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager...
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Validation Specialist
1 month ago
Summit, United States TSR Consulting Services, Inc. Full timeTSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a MES Validation Specialist.Job ID #80107 Rate type: W2 only CommentsMinimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager...
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Validation Engineer
2 months ago
Summit, United States Diversity Nexus Full timeManager feedback from Sanober- manager feedback so far resumes received- NeededCQV needed.. needs CTO temperature mapping with equipment facility experience.. looking for CQV equipment commissioning with calibration.Resume receivedmost of resumes received has computer validation and CSV which manager does not want, not articulate in describing experience,...
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Quality Engineer
1 week ago
Summit, United States SSi People Full timeJob Title: Commissioning/Qualification Specialist / Specific Commissioning and Validation support Location: Summit, NJ (Hybrid)Duration: 12+ monthsPay Rate: 40-45/hr on W2Essential Functions:Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.Support Lifecycle Document Management SystemDevelops...
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Commissioning Engineer
2 weeks ago
Summit, United States Integrated Resources, Inc ( IRI ) Full timeJob Description: Commissioning/Qualification SpecialistLocation: Onsite role, Warren NJDuration - 12 MonthsPay Rate : $45/Hour on W2Job Description: Minimum 50% onsite requiredwork schedule- Normal Business hoursEssential Functions:Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.• Support...
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Summit, United States Rangam Full timePay Scale: $40 - $45 Per hourMinimum 50% onsite required Essential Functions:Support Lifecycle Document Management SystemDevelops protocols, and associated reports while adhering to a change management process.Supports the execution of equipment qualifications and validation protocolsSupervises vendors for qualification functions.Develops written procedures...
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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...
CSV Engineer
2 months ago
PURPOSE AND SCOPE OF POSITION:
The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites through interaction with internal customers and external service providers.
The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation.
With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.
As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Strong working knowledge of MS Windows client and server technologies.
Working knowledge of standard networking principles and technologies.
Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
Ability to work with the end user to identify and document User and Functional Requirements.
Knowledge of pharmaceutical laboratory and manufacturing systems.
Experience executing equipment 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 and Experience:
Required BS degree in Engineering / Computer Science
Minimum 5 years of experience in FDA-regulated industry, with min 3 years’ experience in CSV
DUTIES AND RESPONSIBILITIES:
Essential Functions:
Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
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.
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, and 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 qualification and validation documentation with accuracy, completeness, and compliance to Company 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.
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