![Lorven technologies](https://media.trabajo.org/img/noimg.jpg)
Validation Specialist
4 weeks ago
Position: Validation Specialist
Location: Raleigh, NC
Job Mode: Contract
Job Description:
Job Summary:
The Validation Specialist will be responsible for the validation of computer systems and processes, ensuring compliance with regulatory requirements. This role will involve significant interaction with data analytics and RIM to support and enhance our compliance and validation activities. The ideal candidate will have a strong background in validation processes, data analytics, and regulatory information management.
Key Responsibilities:
- Validation Processes:
- Develop and execute validation protocols (IQ/OQ/PQ) for computer systems and software applications.
- Conduct risk assessments and create validation master plans in accordance with regulatory guidelines.
- Ensure all validation activities comply with GxP, FDA, EMA, and other relevant regulatory standards.
- Data Analytics:
- Utilize data analytics to monitor and assess system performance and compliance.
- Analyze validation data to identify trends, anomalies, and areas for improvement.
- Provide data-driven insights to support decision-making in validation and compliance processes.
- Regulatory Information Management (RIM):
- Ensure that all validation activities align with regulatory requirements and are documented within the RIM system.
- Maintain and manage regulatory documentation and records, ensuring accuracy and compliance.
- Support regulatory submissions by providing validated data and documentation as required.
- Collaboration and Communication:
- Work closely with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Data Management, to ensure successful validation activities.
- Provide training and guidance on validation processes and regulatory compliance to team members.
- Prepare and present validation reports to stakeholders and regulatory bodies as needed.
- Continuous Improvement:
- Identify opportunities to enhance validation processes through the use of data analytics and automation.
- Stay updated with industry best practices, regulatory changes, and advancements in validation technology.
- Lead or participate in continuous improvement initiatives related to validation and regulatory compliance.
Qualifications:
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field. A Master's degree is preferred.
- Proven experience as a Validation Specialist, Validation Engineer, or similar role, with a focus on computer system validation.
- Strong expertise in Data Analytics, with experience using tools like SQL, Python, R, or equivalent.
- Experience with Regulatory Information Management (RIM) systems and regulatory submissions.
- In-depth knowledge of GxP, FDA, EMA, and other relevant regulatory standards.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work independently and as part of a cross-functional team.
- Strong organizational skills and attention to detail.
Preferred Skills:
- Experience in the pharmaceutical, biotechnology, or medical device industry.
- Familiarity with quality management systems (QMS) and electronic document management systems (EDMS).
- Certification in Computer System Validation or related disciplines is a plus.
-
LL01-062824 Validation Specialist
7 days ago
Raleigh, United States Validation & Engineering Group Full timeJob DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking for talented,...
-
CQV Validation Specialist
1 week ago
Raleigh, North Carolina, United States Technical Source Full timeTechnical Source is actively seeking a meticulous and highly organized CQV Validation Specialist. This position entails the initiation, commissioning, and validation of various systems including water generation, clean steam generation, distribution systems, storage tanks, and process gas/air systems.Key Responsibilities of the CQV Validation Specialist...
-
CQV Validation Specialist
1 week ago
Raleigh, North Carolina, United States Technical Source Full timeTechnical Source is actively seeking a meticulous and organized CQV Validation Specialist. This position entails overseeing the initiation, commissioning, and validation of various systems including water generation, clean steam generation, distribution networks, storage solutions, and process gas/air systems.Key Responsibilities of the CQV Validation...
-
CQV Validation Specialist
4 days ago
Raleigh, North Carolina, United States Technical Source Full timeJob OverviewTechnical Source is actively seeking a meticulous and organized CQV Validation Specialist to support our client.This position entails the initiation, commissioning, and validation of various equipment including parts washers, autoclaves, isolators, Biological Safety Cabinets, Laminar Flow Hoods, pumps, welders, and weight booths.Key...
-
Raleigh, North Carolina, United States Experis Full timeAbout the RoleWe are seeking a highly skilled Commissioning, Qualification, and Validation Specialist to join our team at Experis. As a key member of our CQV team, you will be responsible for ensuring the smooth operation of our manufacturing processes and systems.Key ResponsibilitiesCommissioning and Qualification: Perform commissioning, qualification, and...
-
National Accounts Data Validation Specialist
3 days ago
Raleigh, North Carolina, United States GFL Environmental Full timeAbout the RoleAs a Data Validation Specialist for National Accounts at GFL Environmental, you will play a critical role in ensuring the accuracy and integrity of customer data. Reporting to the National Accounts Implementation Supervisor, you will be responsible for setting up new accounts and revising existing accounts for all National Accounts...
-
National Accounts Data Validation Specialist
2 weeks ago
Raleigh, United States GFL Environmental Full timeReporting to the National Accounts Implementation Supervisor, the National Accounts Data Validation Specialist role is responsible for the setup of new accounts and revision of existing accounts for all National Accounts customers. This position will complete customer data entry for new and existing accounts, address inconsistencies of customer data, and...
-
CQV Validation Specialist
1 week ago
Raleigh, North Carolina, United States Technical Source Full timeJob OverviewTechnical Source is seeking a meticulous and highly skilled CQV Validation Engineer to support our client in the field of validation and commissioning.This position involves the initiation, commissioning, and validation of various equipment including parts washers, autoclaves, isolators, Biological Safety Cabinets, Laminar Flow Hoods, pumps,...
-
CQV Validation Specialist
3 days ago
Raleigh, North Carolina, United States Technical Source Full timeJob OverviewTechnical Source is seeking a meticulous and highly skilled CQV Validation Engineer to support our client in their operations.This position entails the initiation, commissioning, and validation of various equipment including parts washers, autoclaves, isolators, Biological Safety Cabinets, Laminar Flow Hoods, pumps, welders, and weight booths.Key...
-
Manufacturing Systems Validation Expert
11 hours ago
Raleigh, North Carolina, United States Experis Full timeAbout the RoleWe are seeking a highly skilled Commissioning, Qualification, and Validation Specialist to join our team at Experis. As a key member of our CQV team, you will be responsible for ensuring the smooth operation of our manufacturing processes and systems.Key ResponsibilitiesCommissioning and Qualification: Perform commissioning, qualification, and...
-
Automotive Sales Specialist
1 week ago
Raleigh, North Carolina, United States Hertz Full timeThe Automotive Sales Specialist plays a crucial role in the sales and financing journey, ensuring top-notch customer service while supporting lot operations and multi-channel sales. This position requires a thorough execution of the sales process, meeting monthly sales objectives, and maintaining high-quality CRM records. Utilizing all acquired sales...
-
Quantitative Analytics Specialist
22 hours ago
Raleigh, North Carolina, United States Marsh & McLennan Companies Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Quantitative Analytics Specialist to join our team at Marsh & McLennan Companies. As a key member of our Financial Services Quantitative Analysis (FSQA) team, you will work closely with clients to develop and implement advanced analytics solutions to drive business growth and improve...
-
Automotive Sales Specialist
1 week ago
Raleigh, North Carolina, United States Hertz Full timeThe Automotive Sales Specialist plays a crucial role in the sales and financing journey, ensuring exceptional customer experiences while assisting with lot operations and multi-channel sales. This position involves a comprehensive execution of the sales process, meeting monthly sales objectives, and maintaining high-quality CRM engagement. Utilizing trained...
-
Automotive Sales Specialist
1 week ago
Raleigh, North Carolina, United States Hertz Full timeThe Automotive Sales Specialist plays a crucial role in the sales and financing journey, ensuring exceptional customer service while assisting with lot operations and multi-channel sales. This position involves executing the sales process thoroughly, meeting monthly sales objectives, and maintaining high-quality CRM records. The specialist will consistently...
-
Practical Nursing Specialist
1 week ago
Raleigh, North Carolina, United States TotalMed Staffing Full timePractical Nursing Specialist - Home CareAbout the PositionJob OverviewWe are seeking a dedicated Practical Nursing Specialist to join our team in providing exceptional home care services. This role is crucial in delivering high-quality nursing care to patients in their own homes, ensuring their comfort and well-being.Key Responsibilities- Deliver nursing...
-
Swimming Pool Maintenance Specialist
4 days ago
Raleigh, North Carolina, United States Aqua Tech Pool Management Full timeSwimming Pool Maintenance Specialist Job OverviewAre you enthusiastic about outdoor work and dedicated to ensuring the upkeep of swimming facilities? Aqua Tech Pool Management is looking for Swimming Pool Maintenance Specialists to uphold the cleanliness and safety of our aquatic environments.Daily Maintenance: Responsible for the thorough cleaning and...
-
Business Development Specialist
3 months ago
Raleigh, United States Consolidated Laundry Equipment LLC Full timeJob DescriptionJob DescriptionPosition: Business Development SpecialistCompany: Consolidated Laundry Equipment LLCLocation: North Carolina, South Carolina, VirginiaJob Type: Full-timeSalary: $50k Plus IncentiveThe Ideal Person: A heart to help. Laundry equipment lasts a long time and it's our goal to constantly help our customer base improve all things...
-
Mailroom Operations Specialist
3 days ago
Raleigh, North Carolina, United States TEKsystems Full timeJob OverviewTEKsystems is looking for a Mailroom Operations Specialist to support a prominent multinational technology organization.The primary responsibility of the Mailroom Operations Specialist is to maintain the facility's standards while executing assigned mailroom tasks effectively.Position Summary:The Mailroom Operations Specialist plays a crucial...
-
Technical Service Specialist
4 days ago
Raleigh, North Carolina, United States Food Management Search Full timeJob Title: Technical Service Specialist Location: Remote Salary: $65-75K plus bonus Job Summary of the Technical Service Specialist: We are seeking a Technical Service Specialist who is proactive, comfortable engaging directly with clients, possesses strong technical writing skills, and can collaborate with the Engineering team to provide product...
-
Pulmonary Care Specialist
1 week ago
Raleigh, Mississippi, United States Covington County Hospital Full timePosition Overview: The Pulmonary Care Specialist is responsible for executing standard practices in the field of respiratory care, focusing on the administration of therapeutic gases and providing mechanical support for patients' breathing needs. This role is crucial in ensuring that patients receive optimal respiratory therapy services.Key...