Validation Lead with Lab Vantage

2 weeks ago


Jersey City, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Validation Lead with 10+ years of experience to with Lab Vantage LIMS implementation team who would be responsible for :
  • Planning and implementation of validation projects for Compliant GxP Computerized Systems, particularly for Lab Vantage LIMS system
  • Creation, Review and in-time delivery of the Validation documentation but not limited to the following:
  • Computer Systems Validation Plan and Report
  • Data Migration Plan and Report
  • URS/FS/CS, Risk assessment
  • Test plan and Report
  • Test cases creation and execution
  • Manage all facets of assigned validation projects while maintaining strong communication on project status and assistance needed
  • Build/Set-up Validation and qualification practices grounds up in line with GxP for both GMP and GLP
  • Coordinate with the application vendor for clarification on the open defects and on the validation deliverables at vendor side
Requirements:
  • Experience in Validation (entire duration) in the Life Sciences and Clinical trial related
  • Experience managing projects (Lead Exp duration)
  • Experience in a regulated manufacturing environment
  • Experience with process and equipment validations
  • Experience with LIMS and Lab Vantage would be a plus
  • Deep understanding of GxP (clinical, pharmacovigilance, laboratory etc.) regulations, 21 CFR Part 11 & other regulations

  • Validation Lead

    2 weeks ago


    Jersey City, United States RxCloud Full time

    Job Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...

  • Validation Lead

    3 weeks ago


    Jersey City, United States RxCloud Full time

    Job Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...

  • Validation Engineer

    2 weeks ago


    Jersey City, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core values. You will work closely with instrument vendors, facilities, IT, and lab...

  • Validation Manager

    2 weeks ago


    Jersey City, 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...

  • SAP Validation Lead

    3 weeks ago


    California City, United States RxCloud Full time

    About the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations...


  • Sioux City, United States Vantage Point Solutions Inc Full time

    Customer Contact SpecialistJob Summary The Customer Contact Specialist's role is to educate customers on broadband services and discuss fiber placement and connection processes with owners of residential homes and small businesses. This role will be required to take detailed field records of the fiber placement plan and relay information to our Outside Plant...

  • Sr Validation Lead

    2 weeks ago


    Foster City, United States eTeam Full time

    Strong GxP Validation Exp, SAP Implementation Exp, Validation Lead SQA/ VALIDATION/AUTOMATION " Must have 8 years of experience in Selenium Quality Assurance. Primary Responsibilities will include the following :- Experience in software test development and including crating/maintaining test automation- frameworks from scratch. Should have exposure to best...


  • Kansas City, United States MEDVACON Full time

    Company DescriptionMEDVACON Life Sciences works with leading pharmaceutical companies to hire consulting, contract and full-time employees to join client organizations. Our focus is providing consulting and talent acquisition services for cGMP Quality and Compliance, Validation and Regulatory for pharmaceutical and biotechnology companies. Job Description...

  • Validations Engineer

    2 weeks ago


    Salt Lake City, United States DISCGENICS INC Full time

    Job DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary:  The Validations Engineer will fill an important need at DiscGenics through helping the company...


  • Foster City, United States HCLTech Full time

    Position - Lab Operation Lead/ Director Type - Full Time Location - Onsite in Foster City, CA Mandatory Skill- Lab Operations and Managing LIS team size 100+ Job Description - Responsible for maintaining the laboratories as a safe, functional, and compliant environment. Coordinate with external instrument/equipment vendors and facilities for installation...

  • SAP Validation Lead

    2 weeks ago


    Texas City, United States eTeam Full time

    JOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end...

  • SAP Validation Lead

    5 days ago


    Texas City, United States eTeam Full time

    JOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end...


  • Salt Lake City, United States DISCGENICS INC Full time

    Job DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary:  The Senior Validations Engineer will fill an important need at DiscGenics through helping the...

  • Medical Lab Scientist

    2 weeks ago


    Lincoln City, United States K.A. Recruiting Full time

    NEW Lead Chemistry MT Opening Northwest Oregon Permanent full time position EVENING shift Requirements Candidates must be actively following or have completed a Medical Laboratory Scientist approved route to meet eligibility criteria for certificatio Chemistry, Lead, Medical, Scientist, Lab, Lab, Healthcare, Staffing

  • R&D Chemist I

    4 weeks ago


    Totowa, New Jersey, United States Englewood Lab, Inc Full time

    The Company Englewood LAB leads the industry among OEM and ODM manufacturing companies in OTC Cosmetics. We manufacture and develop products for more than 80 major brands and trusted partners. Englewood LAB brings extensive expertise in developing and manufacturing a variety of skin care products. Title: Chemist I Reports to: Sr. Chemist Department:...


  • Jersey City, United States Brand Experience Lab Full time

    Embedded Software Engineer About the RoleWe are seeking a highly skilled and experienced Electrical Engineer and Embedded Systems Designer to join our dynamic team. This role is ideal for an individual with a deep understanding of Electrical Engineering principles Circuit Design, and PCB design, as well as hands-on experience with Arduino, ESP32. The...


  • Jersey City, United States Brand Experience Lab Full time

    Job DescriptionJob DescriptionEmbedded Software Engineer About the RoleWe are seeking a highly skilled and experienced Electrical Engineer and Embedded Systems Designer to join our dynamic team. This role is ideal for an individual with a deep understanding of Electrical Engineering principles Circuit Design, and PCB design, as well as hands-on experience...


  • Redwood City, United States Dexterity Full time

    Title: Reliability Validation Engineer Location: Redwood City, California Job Classification: Full Time At Dexterity, we believe robots can positively transform the world. Our breakthrough technology frees people to do the creative, inspiring, problem-solving jobs that humans do best by enabling robots to handle repetitive and physically difficult work. We...


  • Jersey City, New Jersey, United States Brand Experience Lab Full time

    Embedded Software Engineer  About the Role We are seeking a highly skilled and experienced Electrical Engineer and Embedded Systems Designer to join our dynamic team. This role is ideal for an individual with a deep understanding of Electrical Engineering principles Circuit Design, and PCB design, as well as hands-on experience with Arduino, ESP32. The...

  • Delivery Lead

    3 weeks ago


    Jersey City, United States SkillStorm Commercial Services LLC Full time

    * Delivery Lead **Delivery Lead** SkillStorm is seeking a Delivery Lead for our client in Jersey City, NJ. Candidates must be able to work on SkillStorm's W2; not a C2C position. EOE, including disability/vets. **Job Description:** * Support the program manager with BRD delivery, planning and reporting for Fundamental Review of the Trading Book (FRTB) IMA...