Jobs
>
Philadelphia

    IT Validation - Philadelphia, United States - Lifelancer

    Lifelancer
    Lifelancer Philadelphia, United States

    1 day ago

    Default job background
    Description
    About the job IT Validation / Business Analyst (Veeva / LIMS)

    Job Description:
    Our Client is seeking an IT Validation / Business Analyst based at our Cambridge site or remote. This validation/business analyst will be responsible for business analysis and validation of our GxP applications.

    Knowledge and experience with Veeva Quality Vault (QDocs, QMS, LMS), and Lab Information Management system (LIMS) or other lab systems is preferred.

    Deep understanding of the software development life cycle and computerized system validation principles.


    Job Requirements:
    Knowledge of science biology, chemistry, engineering, or related discipline is preferred, or its equivalent. Experience working in a GxP regulated environment, preferably in the biopharma space. Experience working with users from the quality, clinical, and regulatory domain. Experience working with Veeva Systems and SaaS applications. Experience working with LIMS or other lab systems.


    Knowledge and Skills:

    Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.

    Comprehensive understanding of the Software Development Life Cycle, GAMP 5 and regulatory agency requirements.


    Knowledge in following areas:


    o Business analysiso User requirements analysiso System Development Life Cycle (SDLC) and validation requirements/documentation.o Comprehensive understanding of GAMP 5 Risk based approach to GxP system validation.


    Preferred domain knowledge:


    Domain knowledge of Quality, Clinical, and Regulatory processeso Veeva Systems Experience which includes Veeva Quality and Regulatory Vault.o Lab Information Management Experience which includes validation of LIMS systems.

    Perform change management activities in support of system enhancements and user requirements.

    Author validation deliverables per SDLC Author Standard Operating Procedures and Work Instructions Strong ability to comprehend complex problems and apply knowledge to propose potential solutions.

    Analytical skills to be able to understand the needs of stakeholders and work out priorities. Strong written and oral communication skills as well as organizational skills. Demonstrated ability to work effectively under established guidelines and instructions. Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
    We recommend applying via the Lifelancer website at the below link for screening steps & quicker
  • Charter Global

    Validation Specialist

    3 weeks ago

    Charter Global Philadelphia, United States

    The Client is one of the top 4 big firms in the USA. · Job Title: Instrument Validation Specialist · Duration: 6 months contract · Notes: · Looking for an Instrument Validation Specialist - need someone familiar with lab equipment, but the overall project will be for both pharmac ...

  • InsideHigherEd

    validation manager

    3 weeks ago

    InsideHigherEd Philadelphia, United States Administrative Jobs ,

    Duties: This position has multiple responsibilities within the cGMP Cell Manufacturing Facilities group that supports the CVPP. Manage the Preventative Maintenance and Calibration programs to ensure all equipment (centrifuges, freezers, incubators, cell counters, etc.) remain in ...

  • STELLAR CONSULTING GROUP LLC

    Validation Engineers

    2 days ago

    STELLAR CONSULTING GROUP LLC Philadelphia, United States

    Job Description · Job DescriptionValidation Associates is currently in search of Validation Engineers for our pharmaceutical clients nationwide, Multiple positions · All Visas Accepted- OPT/CPT/GC/USC/TN/L2- Multiple Positions- Nationwide. (US Candidates only) · We are actively ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    1 week ago

    Katalyst Healthcares and Life Sciences Philadelphia, United States

    Responsibilities: Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring . · Create/author/execute at a minimum , Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, ...

  • PCI Pharma Services

    Validation Specialist

    3 weeks ago

    PCI Pharma Services Philadelphia, United States

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. · We are PCI. · Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to ...

  • Validation & Engineering Group Inc.

    Sr. Validation Engineer

    1 week ago

    Validation & Engineering Group Inc. Fort Washington, United States

    Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Valid ...

  • a Biopharmaceutical company based out PA

    Process Validation Engineer

    1 week ago

    a Biopharmaceutical company based out PA Philadelphia, United States

    Process Validation Engineer (Contract) · RESPONSIBILITIES · Overseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility. · Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, an ...

  • Precision Medicine Group

    Manager, Validation Engineering

    3 weeks ago

    Precision Medicine Group Philadelphia, United States

    Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. We are an in ...

  • Barry-Wehmiller

    Project Manager, Validation

    2 weeks ago

    Barry-Wehmiller Philadelphia, United States Full time

    Description · Coordinates work activities of multiple functional areas to ensure satisfactory delivery of assigned projects. · Responsible for all aspects of the project life cycle: planning, scope definition, design, execution, and delivery. · Tracks progress against milestones ...

  • Clarkston Consulting

    Computer Systems Validation

    15 hours ago

    Clarkston Consulting Philadelphia, United States

    Job Description · Job DescriptionClarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant ...

  • Iovance Biotherapeutics Inc

    Senior Validation Engineer

    2 days ago

    Iovance Biotherapeutics Inc Philadelphia, United States

    Job Description · Job DescriptionSalary: · Iovance is hosting an onsite Job Fair. · Where: Iovance Cell Therapy Center (iCTC) · Location: 300 Rouse Blvd Philadelphia, PA 19112 · Date: Monday, June 24, 2024 · Time: 12pm to 6pm (EDT) · What to bring: Updated resume · We are H ...

  • Lorven Technologies

    Fully Qualified Navy Validator

    2 weeks ago

    Lorven Technologies Philadelphia, United States Full time

    Job Title: Fully Qualified Navy Validator · Location: Philadelphia, PA (Hybrid) · Duration: Fulltime · Key Responsibilities: · System Validation and Accreditation: Conduct thorough assessments of IT systems, applications, and networks to ensure compliance with Department of De ...

  • PCi Corporation

    Validation Specialist

    2 weeks ago

    PCi Corporation Philadelphia, United States

    Red Lion Road-PA002 · SUMMARY: · The main functions of a Validation Specialist are focused around the qualification of pharmaceutical packaging equipment and validation of the associated processes run on this equipment. These functions include generation and execution of protocol ...

  • Expert In Recruitment Solutions

    Validation Engineer

    2 weeks ago

    Expert In Recruitment Solutions Philadelphia, United States

    · MUST HAVE: · Experience in cleaning validation in the biologics or vaccine industry to include the following: · o Experience in authoring, reviewing, executing and approving validation documents. · o Interface with Quality organization and the ability to defend rationale in va ...

  • RSM US LLP

    FDA Validation and IT Quality Director

    1 week ago

    RSM US LLP Philadelphia, United States

    Job Description · We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, ...

  • RSM US LLP

    FDA Validation and IT Quality Director

    1 week ago

    RSM US LLP Philadelphia, PA, United States

    We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture ...

  • Validation & Engineering Group

    MV01-012324 Sr. Validation Engineer

    3 weeks ago

    Validation & Engineering Group Fort Washington, United States

    Job Description · Job DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engin ...

  • WuXi AppTec

    Senior Quality Assurance Validation Specialist

    1 day ago

    WuXi AppTec Philadelphia, United States

    Overview · Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Con ...

  • Ace American Insurance

    Product Validation Specialist

    2 weeks ago

    Ace American Insurance Philadelphia, United States

    Product Validation Specialist - 8373 · DESCRIPTION/RESPONSIBILITIES: In this role, you will work closely with the NA Digital Consumer Team, product owners, Tech Team, and other members of the Operations group in testing, implementing, and managing products, processes, user accept ...

  • Chubb

    Product Validation Specialist

    1 week ago

    Chubb Philadelphia, United States

    Job Description · Chubb's North American Digital Consumer Division brings together the digital products and services of Chubb's North American consumer businesses. We are a diverse, dynamic, and nimble team that uses technology, smarts, and a customer-centric focus to build and ...