Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

CSV Validation Lead: GxP & FDA Compliance

Katalyst CRO

A leading CRO in the pharmaceutical sector is seeking a CSV Lead to manage the end-to-end Computer System Validation for GxP systems. This role involves developing and reviewing URS, risk assessments, and ensuring compliance with FDA regulations. The ideal candidate will collaborate closely with IT, QA, Labs, and vendors to maintain systems in a validated state. Aiming for a mid-senior level candidate, this position offers unique challenges in a dynamic environment. #J-18808-Ljbffr Katalyst CRO

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the CSV Validation Lead: GxP & FDA Compliance in South Plainfield, NJ vacancy
  •  ...CSV for SAP systems/projects To create| assign and...  ...process improvement and compliance in the assigned module| and...  ...expertise in Computer System Validation (CSV) processes and methodologies...  ...standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific requirements... 
    Suggested

    Katalyst Healthcares and Life Sciences

    South Plainfield, NJ
    2 days ago
  • $137k - $140k

     ...Piscataway, NJ. This role involves managing quality control activities to ensure timely delivery of materials for production and compliance with regulatory standards. The ideal candidate should have a Bachelor's degree in Pharmacy or Chemistry, possess strong analytical... 
    Suggested

    Amneal Pharmaceuticals LLC

    Piscataway, NJ
    2 days ago
  • $94.18k - $114.12k

     ...stakeholders and technical delivery teams. You will lead requirements management, ensuring compliance with GxP standards and enterprise best practices....  ...Salesforce platform standards, system architecture, and GxP/CSV compliance requirements . ~ Support defect... 
    Suggested
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb

    New Brunswick, NJ
    5 days ago
  •  ...stakeholders and technical delivery teams. You will lead requirements management, ensuring compliance with GxP standards and enterprise best practices. This high...  ...platform standards, system architecture, and GxP/CSV compliance requirements. Support defect triage and... 
    Suggested

    United Cerebral Palsy of Georgia

    New Brunswick, NJ
    3 days ago
  • $85k - $105k

     ...all facility/equipment maintenance and supplies. Responsible for maintaining a safe working environment and overseeing safety compliance. Responsible for daily Cycle Counts, Research, Root Cause Analysis, Findings, and Developing Solutions to improve overall... 
    Suggested
    Full time
    Temporary work
    Work experience placement
    All shifts
    Monday to Friday
    Shift work

    M S International

    Edison, NJ
    3 days ago
  •  ...other characteristic protected by law. Description Lead with Purpose. Empower People. Shape Guest Experiences. At...  ...Manage daily operations, including scheduling, payroll, and brand compliance. Partner with Sales, F&B, and Engineering to ensure a... 
    Full time
    Part time
    Work at office
    Immediate start
    Relocation
    Monday to Friday
    Flexible hours
    Shift work
    Night shift
    Weekend work
    Day shift
    Afternoon shift

    Rebel Hospitality New York LLC

    Iselin, NJ
    5 days ago
  •  ...Sports Facilities Companies (SFC) company. SFC is the nation's leading resource for managing and developing sports, recreation,...  ...FOLLOWING: Oversee front-line managers/supervisors to ensure compliance with SFM policies and additional applicable laws Oversee effective... 
    Full time
    Flexible hours
    Night shift

    The Sports Facilities Companies

    Edison, NJ
    5 days ago
  • $90k

     ...functional excellence and budget achievement. The Supervisor ensures adherence to all accident prevention programs and leads operations to ensure compliance with all safety, environmental, operating, regulatory, accounting, ethics and other standards. Responsibilities... 
    Work experience placement
    Local area

    Interstate Waste Services

    Plainfield, NJ
    3 days ago
  • $26 - $34 per hour

     ...SUMMARY & SCOPE The Operations Manager (OM) is responsible for leading through Ulta Beauty's mission, vision, and values in order to...  ...on performance (sales, inventory results, and operational compliance), people (talent acquisition, training and development), and... 
    Full time
    Part time
    Work experience placement
    Work at office
    Local area
    Flexible hours
    Shift work
    Afternoon shift

    Ulta Beauty

    South Plainfield, NJ
    3 days ago
  • $115k - $135k

     ...all facility/equipment maintenance and supplies. Responsible for maintaining a safe working environment and overseeing safety compliance. Perform additional duties as required and or requested. Additionally the candidate must meet the following Education... 
    Full time
    Temporary work
    All shifts
    Monday to Friday

    M S International

    Edison, NJ
    3 days ago
  •  ...health issues. Rutgers, The State University of New Jersey, is a leading national research university and the state of New Jersey's...  ...procedures to maximize quality, efficiency and revenue, while ensuring compliance with state and federal regulations. Working closely with the... 
    Full time
    Contract work
    Seasonal work
    Local area
    Flexible hours
    Shift work

    Rutgers University

    Piscataway, NJ
    1 day ago
  • $50 per hour

     ...ensure the facilities are operating efficiently, safely, and in compliance with all applicable regulations and company standards. Key...  ...mechanical systems Leadership or supervisory experience preferred Valid engineering licenses/certifications preferred (Blue on Blue... 
    Full time
    For contractors
    Work from home

    AB Facility

    Clark, NJ
    1 day ago
  • $75k

     ...ensures adherence to all accident prevention programs and leads operations to ensure compliance with all safety, environmental, operating, regulatory,...  ...Requirements and Qualifications::   ~ Must have a valid drivers license. ~3+ years of experience in transportation... 
    Local area
    Flexible hours
    Shift work
    Night shift

    Interstate Waste Services

    Plainfield, NJ
    14 hours ago
  • $110k

     ...performance. Executes necessary precautions to ensure safety and compliance with Company, OSHA, and other standards and regulations....  ...solid waste operations in which coaching, routing assessments and leading employees # Other Knowledge, Skills or Abilities Required... 
    Full time
    Temporary work
    Work experience placement
    Work at office
    Local area
    Night shift

    Interstate Waste Services

    Plainfield, NJ
    14 hours ago
  • An established industry player is seeking a CSV Engineer to support the implementation of manufacturing and laboratory equipment. This hybrid role involves maintaining compliance for qualified systems, developing protocols, and managing projects in a dynamic environment... 

    TechDigital Group

    Summit, NJ
    2 days ago
  • $111.5k - $127.5k

     ...cylinders while supporting the achievement of compliance with all federal, state, local and...  ...gases Candidates must have valid employment authorization in the U.S. and...  ...Airgas, an Air Liquide company, is a leading U.S. supplier of industrial, medical and... 
    Full time
    Temporary work
    For contractors
    Seasonal work
    Work at office
    Local area

    Airgas

    South Plainfield, NJ
    2 days ago
  •  ...Accelerate your career at RXO RXO is a leading provider of transportation solutions. With cutting-edge technology at the center...  ...interviewing, hiring, disciplining, and resolving issues Ensure compliance with corporate warehouse policies, procedures, and programs... 
    Hourly pay
    16 hours
    Contract work
    Temporary work
    For contractors
    Work at office
    Flexible hours
    Shift work
    Night shift
    Weekend work
    Afternoon shift

    RXO

    Edison, NJ
    3 days ago
  • $222.67k - $292.26k

     ...operations capabilities and functions, with leads/teams in each of these areas:...  ...vendors deliver high-quality services in compliance with GxP and contractual expectations, while enabling...  ...regulatory authority interactions (e.g., FDA inspections) related to clinical operations... 
    Permanent employment
    Full time
    Temporary work
    For contractors
    Local area
    Worldwide
    Flexible hours

    Legend Biotech US

    Somerset, NJ
    5 days ago
  •  ...EOHSI Clinical Center. Establishes clinic-wide operating procedures to maximize quality, efficiency and revenue, while ensuring compliance with state and federal regulations. Works closely with clinic core managers to supervise operational and administrative activities... 
    Contract work

    Rutgers University

    Piscataway, NJ
    2 days ago
  •  ...records Support recruitment and interview coordination Maintain HR compliance and records Assist with payroll coordination Accounting &...  ...with CPA Sales Support & Cold Calling Conduct cold calling and lead generation Follow up with prospects via phone/email Schedule meetings... 

    Vitel Global Communications

    South Plainfield, NJ
    14 hours ago
  • We are seeking an experienced Operations Manager to lead teams, drive operational excellence, and own financial performance. This role...  ...senior leadership to execute operational strategies Ensure compliance with company policies, procedures, and standards Support hiring... 

    Confidential

    Edison, NJ
    4 days ago
  •  ...strategies to enhance customer experience and operational efficiency. Lead, mentor, and manage a team of call center managers and staff,...  ..., and resource allocation to optimize performance. Ensure compliance with company policies, industry regulations, and best practices... 
    Full time

    MTM LLC

    Piscataway, NJ
    4 days ago
  • $100k - $110k

     ..., location managers, and operators while generating positive customer satisfaction. What Your Day-to-day Will Look Like Ensure compliance with specified contract metrics Maintain high standards for all operational activities Hire, train, develop and appraise staff... 
    Hourly pay
    16 hours
    Contract work
    Temporary work
    For contractors
    Work at office
    Flexible hours

    RXO Inc.

    Edison, NJ
    1 day ago
  • $80k

     ...accurate system records related to purchasing and inventory transactions. Assist with export shipping documentation and ensure compliance with required shipping and logistics procedures. Support invoice processing, audit documentation, and compliance-related... 
    Work experience placement
    Work at office
    Flexible hours

    FUJIFILM Corporation

    Edison, NJ
    1 day ago
  •  ...Services, LLC is looking for a Bioinformatics Pipeline Validation Manager in Port Reading, NJ. This role leads a team responsible for validating and optimizing...  ...leadership skills, and expertise in regulatory compliance. Key responsibilities include managing validation... 

    Creative Solutions Services, LLC

    Port Reading, NJ
    3 days ago
  •  ...cause analysis and reporting on trends and recurring issues. Lead the design and implementation of secure, automated CI/CD...  ...drive DevSecOps strategy in alignment with business goals and compliance standards. Embed security controls and tooling (SAST, DAST,... 

    The Custom Group of Companies

    Iselin, NJ
    4 days ago
  •  ...'re hiring a bilingual (English/Spanish) Operations Manager to lead and transform manufacturing operations at our Edison manufacturing...  ...while ensuring Cryopak product quality standards. Ensure compliance with regulatory, safety, and quality standards across all site... 
    Temporary work
    Local area
    Flexible hours

    TCP Reliable Manufacturing, Inc.

    Edison, NJ
    2 days ago
  •  ...involves managing the financial and administrative operations of the NIEHS Center for Environmental Health Sciences grant, overseeing compliance, and organizing various center activities. The ideal candidate should possess a Bachelor's degree, administrative experience, and... 
    Work at office

    Broughton Group

    Piscataway, NJ
    2 days ago
  •  ...Edison, New Jersey. The ideal candidate will oversee daily operations of contract carriers, develop and mentor staff, and ensure compliance with corporate policies. With a strong logistics background and supervisory experience, you'll utilize route planning software to... 
    Contract work

    RXO

    Edison, NJ
    4 days ago
  •  ...across multiple entities in accordance with governing legal agreements and internal procedures, ensuring accuracy, timeliness and compliance with regulatory and control standards Review margin calls bookings for accuracy and completeness when authorizing the margin in... 
    3 days per week

    Perennial Resources International

    Edison, NJ
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to CSV Validation Lead: GxP & FDA Compliance. Be the first to apply!