Validation Specialist

2 weeks ago

Jersey City, New Jersey, United States Hays Recruitment Full time
  • Hays Investor
  • Work for Hays
  • About Us
  • Find Us
  • For Job Seekers
  • For Organizations
    • Australia
    • Austria
    • Belgium
    • Brazil
    • Canada
    • Chile
    • China
    • Colombia
    • Czech Republic
    • Denmark
    • France
    • Germany
    • Hong Kong SAR
    • Hungary
    • Italy
    • Japan
    • Luxembourg
    • Malaysia
    • Mexico
    • Netherlands
    • New Zealand
    • Poland
    • Portugal
    • Romania
    • Singapore
    • Spain
    • Sweden
    • Switzerland
    • Thailand
    • UAE
    • United Kingdom
    • United States
      • For Job Seekers
      • For Organizations
        • Job Search
        • Our Expertise
        • Advice
        • My Account
        Countries

        AMERICAS

        Brazil

        Canada
        EN FR

        Chile

        Colombia

        Mexico

        United States

        EUROPE

        Austria
        DE EN

        Belgium
        FR NL EN

        Czech Republic
        CZ EN

        Denmark
        DA EN

        France

        Germany
        DE EN

        Hungary
        HU EN

        Ireland

        Italy

        Luxembourg
        FR EN

        Netherlands
        NL EN

        Poland
        PL EN

        Portugal

        Romania
        RO EN

        Spain

        Sweden
        SE EN

        Switzerland
        DE EN FR

        UAE

        United Kingdom

        ASIA PACIFIC REGION

        Australia

        China
        CN EN

        Hong Kong SAR

        Japan
        EN JP

        Malaysia

        New Zealand

        Singapore

        Thailand
        • Home
        • Job Search
        • Validation Specialist
Validation Specialist
JOB_52982961169211

View Saved Jobs

Save job
  • Job type
    Contract
  • Location
    New Jersey
  • Profession
    Pharma
  • Industry
    Pharmaceuticals
  • Pay
    $75.00 -$79.00/hr.
Share job

Validation Specialist - Contract - New Jersey - $75.00 -$79.00/hr.

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Validation Specialist in New Jersey.

Role Description

6+ years experience Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system Review validation deliverables for projects which are contracted to third party suppliers Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues Assist in planning, implementing, and documenting user acceptance testing

Review computerized systems validation documents such as: Requirements Specification

Design Specification
CSV Risk Assessment
Test Plans
Test Summary Reports
Data Migration Plan
Pre/Post Executed Test Scripts
Traceability Matrix

Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data or the system Obtain and respond to QA review Participate in establishing standard quality and validation practices Independently assess compliance practices and recommend corrective actions Approve validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action Ability to create documents to an existing document standard. Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries. Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc) Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. Once trained, have the ability to work independently on CSV projects with minimal oversight.

• Review computerized systems validation documents such as:

• Requirements Specification

• Design Specification

• CSV Risk Assessment

• Test Plans

• Test Summary Reports

• Data Migration Plan

• Pre/Post Executed Test Scripts

• Traceability Matrix

• Release to Production Statements

Direct and review testing
Provide guidance on quality issues that affect the integrity of the data or the system
Obtain and respond to QA review
Participate in establishing standard quality and validation practices
Independently assess compliance practices and recommend corrective actions
Approve validated computer system related change requests
Monitor regulatory and inspection trends and advise the business on suitable action
Ability to create documents to an existing document standard.
Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Once trained, have the ability to work independently on CSV projects with minimal oversight.
Ability to perform in a highly matrixed organization structure

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

#LI-DNI

  • Test & Validation Specialist

    1 week ago

    Jersey City, New Jersey, United States Oshkosh Corporation Full time

    Oshkosh Corporation is seeking a highly skilled Test & Validation Specialist to join our team. As a key member of our engineering team, you will be responsible for designing and developing test fixtures and procedures to validate product performance.Responsibilities include but are not limited to:Designing and developing test fixtures and proceduresWorking...

  • Validation Specialist

    1 week ago

    Jersey City, New Jersey, United States Hays Recruitment Full time

    About UsHays Recruitment is a leading recruitment agency specializing in temporary and permanent placement of professionals in various industries. We are committed to building a thriving culture of diversity and inclusion that welcomes people from different backgrounds, perspectives, and experiences.In this Validation Specialist - Contract role, you will...

  • Computer System Validation Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Diverse Lynx Full time

    Job DescriptionAs a Computer System Validation Specialist at Diverse Lynx LLC, you will be responsible for developing and executing validation protocols for computer systems to ensure compliance with regulatory requirements and industry standards. Your key tasks will include creating detailed validation documentation, conducting risk assessments, and...

  • Computer System Validation Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Diverse Lynx Full time

    At Diverse Lynx LLC, we are seeking a highly skilled Computer System Validation Specialist to join our team. In this critical role, you will play a key part in ensuring the accuracy and reliability of our computer systems.The ideal candidate will have experience in developing and executing validation protocols for computer systems, with a strong focus on...

  • Product Validation Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Unitek Technical Services Full time

    Overview of the Position">We are seeking a skilled Product Validation Specialist to join our team at Unitek Technical Services. In this role, you will be responsible for ensuring the quality and integrity of aerospace products by conducting thorough source inspections.">Key Responsibilities">Performing product source inspections, including in-process, final,...

  • Computer Systems Validator

    2 weeks ago

    Jersey City, New Jersey, United States Hays Recruitment Full time

    Job DescriptionWe are seeking a skilled Validation Specialist to join our team at Hays Recruitment. In this role, you will be responsible for ensuring the accuracy and reliability of computer systems in regulated industries. You will apply FDA, MHRA, and other global health authority regulations to the development of these systems. A strong understanding of...

  • Validation and Compliance Manager

    1 week ago

    Jersey City, New Jersey, United States Kasmo Global Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team. The ideal candidate will have a strong background in commissioning, qualification, validation, and maintenance activities within aseptic manufacturing or cell therapy environments.The successful candidate will oversee multiple CQV projects, providing updates and coordinating...

  • Pharmaceuticals Validation Expert

    2 weeks ago

    Jersey City, New Jersey, United States Hays Recruitment Full time

    Role SummaryThe Validation Specialist role at Hays Recruitment involves ensuring the accuracy and reliability of computer systems in regulated industries. This position requires a strong understanding of industry best practices and SOPs, as well as the ability to apply FDA, MHRA, and other global health authority regulations to the development of these...

  • Validation Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Kasmo Global Full time

    Key Responsibilities Perform commissioning, qualification, validation, and maintenance activities within the facility. Oversee multiple CQV projects, providing updates and coordinating with internal teams and external vendors. Lead and support quality investigations, CAPAs, and process improvements to enhance compliance and efficiency. Develop and implement...

  • Validation Specialist

    1 week ago

    Jersey City, New Jersey, United States Kasmo Global Full time

    Key Responsibilities Perform commissioning, qualification, validation, and maintenance activities within the facility. Oversee multiple CQV projects, providing updates and coordinating with internal teams and external vendors. Lead and support quality investigations, CAPAs, and process improvements to enhance compliance and efficiency. Develop and implement...

  • Specialist, MSEO Manufacturing Systems Validation

    1 week ago

    Jersey City, New Jersey, United States Hays Recruitment Full time

    Hays Investor Work for Hays About Us Find Us For Job Seekers For Organizations Australia Austria Belgium Brazil Canada Chile China Colombia Czech Republic Denmark France Germany Hong Kong SAR Hungary Italy Japan Luxembourg Malaysia Mexico Netherlands New Zealand Poland Portugal Romania Singapore Spain Sweden Switzerland Thailand UAE United Kingdom United...

  • Specialist, MSEO Manufacturing Systems Validation

    2 weeks ago

    Jersey City, New Jersey, United States Hays Recruitment Full time

    Hays Investor Work for Hays About Us Find Us For Job Seekers For Organizations Australia Austria Belgium Brazil Canada Chile China Colombia Czech Republic Denmark France Germany Hong Kong SAR Hungary Italy Japan Luxembourg Malaysia Mexico Netherlands New Zealand Poland Portugal Romania Singapore Spain Sweden Switzerland Thailand UAE United Kingdom United...

  • Validation and Verification Professional

    1 week ago

    Jersey City, New Jersey, United States Hays Recruitment Full time

    Job DescriptionWe're seeking a skilled Validation Specialist to join our team. As a key member of our organization, you'll play a crucial role in ensuring the accuracy and reliability of our computerized systems. Your primary responsibilities will include reviewing computerized systems validation documents, directing and reviewing testing, and providing...

  • Data Validation Specialist

    1 week ago

    Jersey City, New Jersey, United States Resource Informatics Group Full time

    About Resource Informatics GroupWe are a leading provider of data validation services. Our team is dedicated to ensuring the accuracy and integrity of client data.Job DescriptionWe are seeking a highly skilled CSV validation engineer to join our team. The successful candidate will be responsible for validating large datasets, identifying errors, and...

  • Senior Validation Specialist

    4 days ago

    Jersey City, New Jersey, United States Piper Companies Full time

    Company OverviewPiper Companies is a leading pharmaceutical organization seeking an experienced Validation Engineer to work on-site in Raritan, NJ.The selected candidate will be responsible for providing technical expertise in commissioning, qualification, validation maintenance, and cleaning/sterilization processes while ensuring compliance with GMP and FDA...

  • Computer System Validation Expert

    1 week ago

    Jersey City, New Jersey, United States Hays Recruitment Full time

    Role DescriptionThe Validation Specialist plays a critical role in ensuring the accuracy and reliability of our computerized systems. Your primary responsibilities will include reviewing computerized systems validation documents, directing and reviewing testing, and providing guidance on quality issues that affect the integrity of the data or the...

  • Process Validation Lead

    2 weeks ago

    Jersey City, New Jersey, United States Kasmo Global Full time

    About UsKasmo Global is a company dedicated to delivering high-quality pharmaceutical products that meet regulatory standards.Job Role:We are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring compliance with cGMP regulations and FDA/EU guidelines through commissioning, qualification,...

  • Financial Risk Validation Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Sumitomo Mitsui Financial Group, Inc. Full time

    About SMBC GroupSMBC Group is a top-tier global financial institution with a rich 400-year history. Headquartered in Tokyo, the Group offers a diverse range of financial services, including banking, leasing, securities, credit cards, and consumer finance.The Group has a significant presence in nearly 40 countries across the Americas, Europe, and Asia. Its...

  • Model Risk Validation Associate

    3 weeks ago

    Jersey City, New Jersey, United States Sumitomo Mitsui Financial Group, Inc. Full time

    SMBC Group is a top-tier global financial group. Headquartered in Tokyo and with a 400-year history, SMBC Group offers a diverse range of financial services, including banking, leasing, securities, credit cards, and consumer finance. The Group has more than 130 offices and 80,000 employees worldwide in nearly 40 countries. Sumitomo Mitsui Financial Group,...

  • Software Validation Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Clario Tech Full time

    Benefits of Working at Clario TechAs a valued member of our team, you can expect to receive a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development. Our company culture emphasizes innovation, collaboration, and continuous learning, providing a dynamic and supportive work environment.Equal...