![Artech](https://media.trabajo.org/img/noimg.jpg)
Validation - Validation Specialist
4 weeks ago
Job Description: Validation Specialist
Warren, NJ--Onsite
Work Schedule: Mon - Fri, Business Hours
6 months contract
The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system related issues, and technical writing and execution. Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.
1. Required Competencies: Knowledge, Skills, and Abilities:
• Working understanding of validation concepts and requirements.
• Intermediate written and verbal communication skills.
• Knowledge of cGMP.
• Critical reasoning and decision making skills.
• Knowledge of validation industry and regulatory requirements.
• Ability to work independently and participate in a team.
• Work and time management skills.
• Working proficiency in Client Word, Outlook, Excel, PowerPoint, and Project.
2. Duties and Responsibilities:
• Performs validation document generation, program management, and protocol execution activities.
• Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
• Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
• Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
• Protocol execution and project activities.
• Execute qualification activities with oversight.
• Participate in department and site project teams.
• Perform qualification activities according to site objectives and timelines.
• Edit department SOPs and generate basic revisions as required.
• Execute CAPA plans, risk assessments, investigations, and root cause analysis.
• Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
• Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
• Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
Performs general administrative and organizational activities.
• Management of time and work deliverables, regular interface and reporting to management.
• Complete regulatory, site, and department training requirements on a timely basis.
Perform other tasks as assigned.
3. Education and Experience:
• Bachelor’s degree preferred, preferably in Science or Engineering.
• 8 years relevant work experience required.
• An equivalent combination of education, experience and training may substitute.
4. Working Conditions
• The incumbent may be required to gown and operate in classified manufacturing environments.
-
Validation Specialist
4 weeks ago
Stafford Twp, United States Mindlance Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
4 weeks ago
Stafford Twp, United States Axelon Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
4 weeks ago
Stafford Twp, United States Axelon Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
3 weeks ago
Stafford Twp, United States Mindlance Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
4 weeks ago
Stafford Twp, United States On-Board Companies Full timeOn-Board Scientific is hiring a Validation Specialist based out of Warren, NJ! For immediate consideration please send your resume to 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....
-
Validation Specialist
3 weeks ago
Stafford Twp, United States Pyramid Consulting Full timeImmediate need for a talented Validation Specialist. This is a 06+ Months Contract opportunity with long-term potential and is located in Warren, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: (phone number removed) Pay Range: $55 - $62/hour. Employee benefits include, but are not limited to, health...
-
Equipment Validation Engineer
4 weeks ago
Stafford Twp, United States Artech Full timeEquipment Validation Engineer Warren, NJ 100% Onsite Required Required Skills: BS in Engineering or Science related discipline required Minimum 3 years of experience in FDA-regulated industry. Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators...
-
Validation Engineer
1 week ago
Stafford Twp, United States On-Board Companies Full timeOn-Board Services is hiring a Validation Engineer in Warren, NJ! For immediate consideration please send your resume to 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...
-
Stafford Twp, United States TechDigital Corporation Full timePurpose and Scope: This role supports the successful operation of facilities, laboratories, and business functions at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely...
-
Validation Engineer
3 weeks ago
Plainsboro Twp, United States Kelith Group Inc Full timeKelith Group Inc has openings for the positions of Validation Engineer with master’s degree in Mechanical/Manufacture Engineering, Management, or related and 1 year of exp in executing Engineering test plans (ETP) for new and modified systems/equipment. Develop protocols for validation/testing of eq...
-
Validation Engineer II
2 months ago
Branchburg Twp, United States Amneal Pharmaceuticals Full timeJob Summary The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes. Essential Functions Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification...
-
Cranberry Twp, United States CoreTek Labs Full timePosition: Hardware Verification and Validation Engineer Location: 500 Cranberry Woods Drive Cranberry Township, PA 16066 Duration: Long-term Contract Experience: 8+ years Job Description: Extensive experience in Linux internals. Experience in Bus & Protocol Analyzer such as CATC USB Chief, Wireshark network packet analyser, Beagle I2C/SPI, oscilloscope,...
-
Validation Engineer III
4 weeks ago
Branchburg Twp, United States Amneal Pharmaceuticals Full timeJob Summary The Validation Engineer III performs validation and engineering activities; conducts development studies; and monitors, analyzes and assists in improving pharmaceutical systems and processes. Provides detailed reports to management. Essential Functions Design, develop and execute validation documents, define validation strategy. Design, review...
-
Validation Engineer III
2 weeks ago
Branchburg Twp, United States Amneal Pharmaceuticals Full timeJob Summary The Validation Engineer III performs validation and engineering activities; conducts development studies; and monitors, analyzes and assists in improving pharmaceutical systems and processes. Provides detailed reports to management. Essential Functions Design, develop and execute validation documents, define validation strategy. Design, review...
-
Branchburg Twp, United States AbbVie Full timeJob Description Onsite position in our Branchburg, NJ, location Purpose: An engineering professional who works with project owners, subject designers/engineers, and other project team members to plan and complete tasks associated with commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, processes,...
-
Senior Validation Engineer
7 days ago
Branchburg Twp, United States AbbVie Full timeAn engineering professional who works with project owners, subject designers/engineers, and other project team members to plan and complete tasks associated with commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, processes, etc.in line with project, operations and quality objectives. Additionally,...
-
Senior Engineer, Validation Commissioning
2 weeks ago
Branchburg Twp, United States AbbVie Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
-
Hardware Verification and Validation Engineer
2 weeks ago
Cranberry Twp, United States Lateral Systems Inc Full timeTitle : Hardware Verification and Validation Engineer” Location : 500 Cranberry Woods Drive Cranberry Township, PA 16066 Extensive experience in Linux internals. Experience in Bus & Protocol Analyzer such as CATC USB Chief, Wireshark network packet analyser, Beagle I2C/SPI, oscilloscope, multimeters etc. Experience in Performance testing and Memory...
-
Hardware Verification and Validation Engineer
2 weeks ago
Cranberry Twp, United States Lateral Systems Inc Full timeTitle : Hardware Verification and Validation Engineer” Are you the right applicant for this opportunity Find out by reading through the role overview below. Location : 500 Cranberry Woods Drive Cranberry Township, PA 16066Extensive experience in Linux internals. Experience in Bus & Protocol Analyzer such as CATC USB Chief, Wireshark network packet...
-
System Readiness Specialist IV
1 month ago
Stafford, United States Skylla Engineering Full timeSkylla Engineering Ltd. is seeking a dedicated and experienced System Readiness Specialist IV to join our dynamic team. This full-time, regular position is designed for a mid-career professional who is ready to take on a challenging role within our organization. The successful candidate will be based in Virginia and will play a pivotal role in ensuring the...