We have other current jobs related to this field that you can find below
-
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...
-
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,...
-
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...
-
Validation Engineer
3 months ago
Summit, United States Joulé Full timeJob Title: Validation Engineer Location: Summit, NJ Type: Contract Responsibilities Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation...
-
Validation Engineer
2 months 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...
-
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...
-
Validation Engineer
1 month ago
Summit, United States Axelon Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
-
Validation Engineer
3 months ago
Summit, United States System One Holdings, LLC Full timeJob Title: Validation Engineer Location: Summit, NJ Type: Contract Responsibilities Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation...
-
Validation Engineer
4 weeks ago
Summit, United States Axelon Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
-
Lab Computing/ Desktop Engineer
2 months ago
Summit, United States VALIDATION ASSOCIATES LLC Full timeJob DescriptionJob Description1 / 3Business Intake Form Job Posting Details: REQ 741-1 Hiring Manager: Deenes Juarez Morales Job Title: Lab Computing Analyst Total Positions: 1Selected Rate Template: $44.00Target Start Date: 7/15/2024Expected End Date: 1/31/2024New or Replacement Req: NewSourcing: IT DlistBusiness Overview:End Client: OneSourceJob Class:...
-
Engineering - Validation Engineer
4 weeks ago
Summit, United States Aircon Engineering Inc Full timeMust have : Strong knowledge on QA processes, Testing activities (Both Agile & Waterfall), Leadership skill to manage team Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. Job Description : Strong knowledge of STLC phases (Agile & Waterfall) and Testing types. Work as a member of one of our...
-
Equipment Validation Specialist
6 days ago
Summit, New Jersey, United States LanceSoft, Inc. Full timePosition: Equipment Commissioning & Qualification EngineerCompany: LanceSoft, Inc.Overview:The Equipment Commissioning & Qualification Engineer plays a crucial role in ensuring the effective implementation of laboratory equipment across multi-use sites. This position involves collaboration with both internal stakeholders and external service providers to...
-
Validation Engineering Specialist
6 days ago
Summit, New Jersey, United States Project Farma (PF) Full timeOpportunity with Project Farma (PF)Project Farma (PF) is a prominent entity in the life sciences sector, leading the way in innovative patient care solutions. We are in search of a dedicated professional to enhance our dynamic team and contribute significantly to improving patient outcomes globally.About UsAt Project Farma (PF), we specialize in consultancy...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Quality Assurance
5 days ago
Summit, New Jersey, United States Aircon Engineering Inc Full timePosition Overview:We are seeking a dedicated Validation Specialist to join our team at Aircon Engineering Inc. This role requires a robust understanding of Quality Assurance processes and testing methodologies across various project environments.Key Responsibilities:- Demonstrate a strong grasp of Software Testing Life Cycle (STLC) phases, including both...
-
Project Engineer
4 weeks ago
Summit, United States System One Full timeProject Engineer Direct Hire Salary: $100k - $125k Project Engineer Responsibilities Review, understand and execute the scope as defined in the order entry package – both technically and commercially Prepare GAANT chart for project, update changes in real time and communicate with customer when changes occur Manage all aspects of the project to...
Validation Engineer
2 months ago
Job Title : Validation Engineer
Location : Summit, NJ
Type:
Contract
Responsibilities
Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
Develops qualification 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 equipment qualification and validation activities.
Develops validation/qualification deliverables such as Validation Plans, Requirements
Specifications, Traceability Matrices, Summary Reports, Change Controls.
Manages projects of limited scope and complexity within their functional area:
Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
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 Celgene 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 equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
Provides technical support and guidance on equipment and computer systems qualification and validations issues.
Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
Regulatory Responsibilities
Ensure equipment, facilities and programs are maintained in compliance.
May be called upon as SME in both internal and regulatory audits.
Requirements
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Experience in the qualification of cell therapy equipment a plus
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multi?tasking ability in conjunction with proven organizational skills. 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.
Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Education and Experience:
BS in Engineering or Science related discipline required
Minimum of 5 years’ experience performing/supporting activities in a GMP environment.
Minimum of 3 years’ experience in equipment, facility or utility qualification
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3
#J-18808-Ljbffr
