Jobs
>
Durham

    CSV Engineer - Durham, United States - Verista

    Verista
    Verista Durham, United States

    Found in: Appcast Linkedin GBL C2 - 2 days ago

    Default job background
    Description
    Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

    Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

    Company Culture Guidelines & Values:

    • We empower and support our colleagues
    • We commit to client success at every turn
    • We have the courage to do the right thing
    • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
    • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

    Responsibilities:

    • Documenting impact and risk assessments as part of a team
    • Completing user interface testing, software verification, and complete alarm testing on automated systems
    • Developing, reviewing, and executing testing documentation
    • Making recommendations for design or process modification based on test results when executing test scripts
    • Hands on experience with lab techniques and general lab analytical operations
    • Understanding of baselined lab standards and system suitability verification
    • Basic experience with IT system formats, configurations, and workflows
    • General understanding of the business processes supporting one or more domains, such as: R&D, Clinical, Quality System Management, Supply Chain & Logistics, Commercialization
    • Review and revision of all IT CSV project and system deliverables including but not limited to:
      • Plans
      • Requirements
      • Specifications
      • Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc
      • Summary Reports
      • Change Controls
    • Review system operational and administration procedures to ensure they are adequate
    • Document any findings of non-compliance
    • Assist with strategy regarding remediation activities
    • Assist with review of remediation activities

    Requirements

    • Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor
    • Ability to work as part of a team
    • Experience in GMP regulated environment
    • Proven attention to detail and organization in project work
    • Capable of working on assigned tasks without mentorship
    • Demonstrated ability to generate CSV deliverables independently
    • Ability to work independently and as part of a team, with the ability to transition between the two

    Benefits

    Why Choose Verista?
    • High growth potential and fast-paced organization with a people-focused culture
    • Competitive pay plus performance-based incentive programs
    • Company-paid Life, Short-Term, and Long-Term Disability Insurance
    • Medical, Dental & Vision insurances
    • FSA, DCARE, Commuter Benefits
    • Supplemental Life, Hospital, Critical Illness and Legal Insurance
    • Health Savings Account
    • 401(k) Retirement Plan (Employer Matching benefit)
    • Paid Time Off (Rollover Option) and Holidays
    • As Needed Sick Time
    • Tuition Reimbursement
    • Team Social Activities (We have fun)
    • Employee Recognition
    • Employee Referral Program
    • Paid Parental Leave and Bereavement

    For more information about our company, please visit us at

    For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

    • Verista is an equal opportunity employer

  • Verista

    CSV Engineer/Analyst

    Found in: Lensa US 4 C2 - 3 days ago


    Verista Durham, United States

    Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies ...

  • Verista

    CSV Engineer/Analyst

    Found in: ZipRecruiter Test10S US C2 - 2 days ago


    Verista Durham, United States

    Job Description · Job DescriptionVerista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help research ...

  • Serigor Inc.

    Integration Engineer

    Found in: ZipRecruiter Test10P US C2 - 2 days ago


    Serigor Inc. Durham, United States

    Job Description · Job DescriptionJob Title: Integration Engineer (HYBRID) · Location: Durham, NC · Duration: 12+ Months · Job Description: · The client seeks a highly technical resources to serve as a Data Integration, API and ETL developer for creating real-time, on-demand, batc ...

  • Biogen

    Head of Site Engineering

    Found in: Lensa US 4 C2 - 1 day ago


    Biogen Durham, United States

    Job Description · About This Role: · The Head of Site Engineering & Facilities is responsible for managing all engineering & facilities at the site supporting manufacturing, laboratory, office, and the rest of site infrastructure operations. This role is accountable for directing ...

  • Kriya Therapeutics

    associate director, quality assurance validation

    Found in: Careerbuilder One Red US C2 - 1 day ago


    Kriya Therapeutics Morrisville, NC , USA, United States

    Who You Are · The Associate Director, Quality Assurance Validation plays a critical role in ensuring the integrity, compliance, and reliability of equipment, methods, processes, and computerized systems within the GMP environment. This position provides support and quality assura ...

  • eTeam

    Technical Lead

    Found in: Lensa US 4 C2 - 3 days ago


    eTeam Raleigh, United States

    CSV, Computer System Validation, Clinical Systems, periodic review and audit experienceKeywords: CSV, Computer System Validation, Clinical Systems, Safety Systems, Infrastructure Qualification, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulationsRoles and ResponsibilitiesMust Have ...

  • eTeam

    Technical Lead

    Found in: Lensa US 4 C2 - 2 days ago


    eTeam Raleigh, United States

    CSV, Computer System Validation, Clinical Systems, periodic review and audit experience · Keywords : CSV, Computer System Validation, Clinical Systems, Safety Systems, Infrastructure Qualification, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulations · Roles and Responsibilities ...

  • Global Channel Management

    Senior IT CSV Analyst

    Found in: Lensa US 4 C2 - 12 hours ago


    Global Channel Management Raleigh, United States

    Experienced IT Professional with a Focus on Computer System Validation in Pharmaceutical Industry · Qualifications · Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related field · Minimum of 5+ years of experience working with Computer S ...

  • BGSF

    Azure Data Engineer

    Found in: Lensa US 4 C2 - 12 hours ago


    BGSF Raleigh, United States

    4 days ago · Be among the first 25 applicants · Our client is seeking a talented and experienced Azure Data Engineer to join our team. The ideal candidate will have a strong background in data engineering, Azure Data Factory (ADF), and Azure Synapse, along with experience ingest ...

  • Biogen

    Head of Site Engineering

    Found in: Lensa US 4 C2 - 3 days ago


    Biogen Raleigh, United States

    Head of Site Engineering & Facilities, RTP Pharma · Full-time · Region: US · About This Role: · The Head of Site Engineering & Facilities is responsible for managing all engineering & facilities at the site supporting manufacturing, laboratory, office, and the rest of site infra ...

  • CRB

    Director, CQV

    Found in: ZipRecruiter Test10P US C2 - 2 days ago


    CRB Cary, United States

    Job Description · Job DescriptionCompany Description · CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,600 employees provide best-in-class solut ...

  • Acropolis Engineers

    Automation Project Engineer

    Found in: Lensa US 4 C2 - 3 days ago


    Acropolis Engineers Raleigh, United States

    Job DescriptionJob Description · We are looking for a motivated Automation Project Engineer who can support projects from beginning to end. Specifically, to assess, track and monitor projects from cradle to grave and to ensure increased demand and marketability with the possibil ...