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

  • Validation Engineer

    1 week 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...


  • 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...

  • 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...


  • 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...


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

    About Kasmo GlobalKasmo Global is a leading pharmaceutical manufacturer dedicated to delivering high-quality products that meet regulatory standards.Job Title:We are seeking a skilled Regulatory Compliance Expert to join our team. In this role, you will be responsible for ensuring regulatory compliance through commissioning, qualification, validation, and...


  • Jersey City, New Jersey, United States EPM Scientific Full time

    Key ResponsibilitiesLead and execute system validation activities to ensure computerized systems meet operational requirements and comply with GxP regulations.Develop and execute comprehensive validation documentation, including validation plans, test plans, test scripts, and validation summary reports.Perform risk assessments to evaluate GxP applicability,...


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

    About the RoleThis is an exciting opportunity to join a leading pharmaceutical company as a Validation Engineer (CSV/CQV). The selected candidate will have the chance to work on complex projects, develop their skills, and contribute to the company's growth and success. We are looking for a motivated and detail-oriented individual who can thrive in a...


  • Jersey City, New Jersey, United States SMBC Group Full time

    The anticipated salary range for this role is between $82,000.00 and $96,000.00. The specific salary offered to an applicant will be based on their individual qualifications, experiences, and an analysis of the current compensation paid in their geography and the market for similar roles at the time of hire. The role may also be eligible for an annual...


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

    ResponsibilitiesAs a Validation Engineer (CSV/CQV), you will be responsible for conducting IQ, OQ, and PQ activities, validating new laboratory equipment and methods, supporting software updates, and creating SOPs, safety protocols, and work instructions.


  • 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

    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...


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

    Job Title: Validation Engineer (CSV/CQV)Piper Companies is seeking an experienced Validation Engineer (CSV/CQV) to work in Raritan, NJ. The ideal candidate will provide technical expertise for commissioning, qualification, validation maintenance, and cleaning/sterilization processes while ensuring compliance with GMP and FDA standards.Job ResponsibilitiesThe...


  • Jersey City, New Jersey, United States SMBC Full time

    Key ResponsibilitiesConduct end-to-end validations and reviews of BSA/AML/Fraud models, assessing model risk from various aspects, including conceptual soundness, data quality, model/scenarios design, model usage, model implementation, model performance, model control, and ongoing performance monitoring.Identify model deficiencies through validations,...


  • 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,...


  • Jersey City, New Jersey, United States SMBC 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,...


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

    About SMBC GroupSMBC Group is a leading global financial institution providing a wide range of financial services, including banking, leasing, securities, credit cards, and consumer finance. With a rich history spanning over 400 years, the Group has established a strong presence in nearly 40 countries across the Americas, Europe, and Asia.Our extensive...


  • Jersey City, New Jersey, United States RevereIT LLC Full time

    Job DescriptionThe successful candidate will be responsible for overseeing engineering and qualification projects related to (Redacted - proprietary info).This person will fill in for the full-time Project Engineer who is going on maternity leave.They will need a technical background in qualification, but won't be conducting the execution.Project management...


  • Jersey City, New Jersey, United States SMBC Group Full time

    Role Description SMBC is seeking a Model Risk Management Associate with a strong project management background to join the Model Risk Management Team. The role is responsible for the execution and delivery of projects in model risk management. Reporting to the Risk Model Validation Executive Director, this person will play a crucial role partnering...


  • Jersey City, New Jersey, United States Societe Generale Corporate and Investment Banking - SGCIB Full time

    ResponsibilitiesThe Third-Party Risk Management (TPRM) Program provides risk review and challenge over the third-party management lifecycle which includes planning, due diligence, contract management, ongoing monitoring, and termination of third-party relationships.As a senior member of the team, the TPR Validation Manager is a critical role in the TPRM...


  • 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,...