Validation Manager

2 weeks ago

Jersey City, New Jersey, United States Primary Recruiting Services Full time
Responsibilities
  • Responsible for validation programs in support of GMP manufacturing
  • Responsible for facility, utility and equipment qualification programs
  • Responsible for QA role in process and assay validation programs
  • Review or author validation related documents such as design specification, URS, FAT, SAT, IQ, OQ, PQ for utility and equipment
  • Assume QA lead role in software validation
  • Maintain and update validation master plans
  • Execute validation protocols as required
  • Oversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturing
  • Supervisor, mentor validation staff with the goal of building a sustaining validation team
  • Serve as the primary QA representative for interaction with internal function departments and contractor on validation activities
Qualification
  • BS/MS in life science or related field
  • 12+ years experience in drug/biologics industry in GMP production environment in roles of validation/engineering
  • 10+ years experience in facility, utility, equipment, instrument validation
  • Experience in biotechnology facility validation is required
  • Familiar with GMP operational principles and practices
  • QC experience helpful
  • Works independently, self-motivated, and results oriented

  • GxP Validation Manager

    4 days ago

    Jersey City, New Jersey, United States beBee Careers Full time

    About the Role:We are looking for a highly experienced GxP Validation Manager to lead system validation and compliance activities.The successful candidate will be responsible for ensuring that systems and applications meet regulatory requirements, and provide assurance services to ensure compliance.Key responsibilities will include review of systems,...

  • Validation Engineer

    4 weeks ago

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

    Piper Companies is currently seeking an experienced Validation Engineer (CSV/CQV) in Raritan, NJ to work for an industry leading Pharmaceutical company. Responsibilities for the Validation Engineer (CSV/CQV) Provide technical expertise for commissioning, qualification, validation maintenance, and cleaning/sterilization processes while ensuring compliance...

  • Validation Specialist

    4 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 Specialist

    3 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...

  • Model Validation Expert

    6 days ago

    Jersey City, New Jersey, United States beBee Careers Full time

    Salary and BenefitsThe anticipated salary range for this role is between $213,000.00 and $235,000.00.Job DescriptionThis position provides day-to-day support to model risk management activities in the Risk Management Department's Model Validation Group.As part of the Americas Division, the group develops and enhances the Model Risk Management framework to...

  • Validation Specialist

    5 days ago

    Jersey City, New Jersey, United States beBee Careers Full time

    Job Description:We are seeking a skilled Validation Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements across various systems and applications.The ideal candidate will have extensive experience in CSV activities, specifically in GxP related applications such as SAP Systems, Product...

  • Validation Lifecycle Specialist

    21 hours ago

    Jersey City, New Jersey, United States beBee Careers Full time

    **Job Description:**The Senior Validation Engineer will be responsible for developing project-specific validation plans and strategies, managing and executing multiple projects to meet client priorities, and providing a practical approach to problem-solving.The ideal candidate will have a strong understanding of validation principles, concepts, practices,...

  • Quantitative Validation Specialist

    5 days ago

    Jersey City, New Jersey, United States beBee Careers Full time

    About the RoleWe are seeking an experienced Quantitative Validation Specialist to join our Model Risk Management Team. In this role, you will be responsible for overseeing enterprise-wide MRM and supporting front-line units in leading model risk.ResponsibilitiesPerform hands-on validations and reviews, write quality model validation reports, and provide...

  • Senior Validation Engineer

    2 weeks ago

    Jersey City, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects. Prepare and execute commissioning / validation lifecycle documents. Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development,...

  • Financial Model Validator

    6 days ago

    Jersey City, New Jersey, United States DTCC Full time

    Overview of ResponsibilitiesThe Associate Director, Senior Quantitative Analyst will be responsible for performing hands-on validations and reviews, writing quality model validation reports, collaborating with model owners, developers, and users, and formulating model validation and review summary and presenting findings to the Model Risk Governance Council...