See more Collapse

CSV Engineer/Analyst

2 months ago

Durham, United States Verista Full time
Job DescriptionJob 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

CSV Engineer/Analyst 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
  • Strong CSV QA/DI knowledge needed

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 Verista.com

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.

We have other current jobs related to this field that you can find below

  • CSV Engineer

    3 weeks ago

    Durham, United States DPS Group LLC Full time

    Summary ADPS is looking for a CSV Engineer in Durham, NC to support a client. The client site is upgrading the DeltaV software, as well as replacing the hosting hardware. As a part of the onboarding the new hardware and software , computer system validation work will be required to meet site Validation requirements. This will include but not be limited...

  • CSV Engineer

    3 weeks ago

    Durham, United States DPS Group LLC Full time

    Summary ADPS is looking for a CSV Engineer in Durham, NC to support a client. The client site is upgrading the DeltaV software, as well as replacing the hosting hardware. As a part of the onboarding the new hardware and software , computer system validation work will be required to meet site Validation requirements. This will include but not be limited...

  • Senior Software Quality Engineer

    3 weeks ago

    Durham, United States GRAIL, Inc. Full time

    GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and...

  • Senior Software Quality Engineer

    4 weeks ago

    Durham, United States GRAIL, Inc. Full time

    GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and...

  • IT Lab System Support Analyst LOCATED IN GENEVA, SWITZERLAND

    5 days ago

    Durham, North Carolina, United States KBI BioPharma Full time

    Job Description IMPORTANT: This position is located in GENEVA, Switzerland Job responsibilities: We are looking for a Lab Systems Support Analyst for our new, state-of-the-art manufacturing facility being built in Geneva. In this role you would be joining a small, rapidly growing and highly motivated team setting up the busines in Geneva while drawing on...

  • Engineer Business Analyst

    2 weeks ago

    Durham, United States NetApp Full time

    Title: Engineer Business Analyst Location: Bangalore, Karnataka, IN, 560071 Requisition ID: 125569 About NetApp We’re forward-thinking technology people with heart. We make our own rules, drive our own opportunities, and try to approach every challenge with fresh eyes. Of course, we can’t do it alone. We know when to ask for help, collaborate with...

  • Software Engineer

    2 days ago

    Durham, United States Mastech Digital Full time

    Title : Software EngineerLocation: Durham, NCDuration: 12+ monthsNO C2C!Candidates should understand the fundamentals of software, particularly object oriented programming (C#, JAVA). Manufacturing experience is preferred.Scope of Position:A junior software engineer responsible for developing software to support equipment integration. You will use your...

  • Software Engineer

    8 minutes ago

    Durham, United States Mastech Digital Full time

    Title : Software Engineer Location: Durham, NC Duration: 12+ months NO C2C! Candidates should understand the fundamentals of software, particularly object oriented programming (C#, JAVA). Manufacturing experience is preferred. Scope of Position: A junior software engineer responsible for developing software to support equipment integration. You will use...

  • Integration Engineer

    1 month ago

    Durham, United States Serigor Inc Full time

    Job Title: Integration Engineer (HYBRID)Location: Durham, NCDuration: 12+ MonthsJob Description:The client seeks a highly technical resources to serve as a Data Integration, API and ETL developer for creating real-time, on-demand, batch and scheduled data interfaces and processing between systems and applications, both internal and external.This...

  • Software Engineer

    4 days ago

    Durham, United States 9992 Full time

    Job DescriptionJob DescriptionEducation: BS in Software Engineering or related technical degreeExperience: 0 to 3+ yearsInterview process: Phone screen, then onsite, possible video interview with team members located in Corning Manager is willing to consider new BS graduates with 0 experience. Candidates should understand the fundamentals of software,...

  • Integration Engineer

    4 weeks ago

    Durham, United States Serigor Inc Full time

    Job 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, batch and scheduled data interfaces and processing between systems and applications, both internal and external. This...

  • Integration Engineer

    2 months ago

    Durham, United States Serigor Inc. Full time

    Job DescriptionJob DescriptionJob Title: Integration Engineer (HYBRID)Location: Durham, NCDuration: 12+ MonthsJob Description:The client seeks a highly technical resources to serve as a Data Integration, API and ETL developer for creating real-time, on-demand, batch and scheduled data interfaces and processing between systems and applications, both internal...

  • Integration Engineer

    3 weeks ago

    Durham, United States Serigor Inc. Full time

    Job DescriptionJob DescriptionJob Title: Integration Engineer (HYBRID)Location: Durham, NCDuration: 12+ MonthsJob Description:The client seeks a highly technical resources to serve as a Data Integration, API and ETL developer for creating real-time, on-demand, batch and scheduled data interfaces and processing between systems and applications, both internal...

  • Integration Engineer

    1 month ago

    Durham, United States Crescens Full time

    Job title: Integration Engineer Location: Durham, NC Duration: 12+ months Type: ContractShort Description: • The client requires the services of a Senior Integration Engineer to administer, design, implement, and oversee the integration solutions using the Mule Soft Any point Platform. Job Description: • The Client seeks highly technical resources to...

  • Senior Business Analyst

    3 weeks ago

    Durham, United States Fidelity Investments Full time

    Job Description: Position Description: Performs analysis on large data sets for system development projects using large data tools.-- Microsoft Excel, Microsoft Access, and Atlassian JIRA. Analyzes data and ensures systems are functioning according to detailed business requirements using Project and Portfolio Management (PPM) methodologies. Designs core...

  • Senior Business Analyst

    1 week ago

    Durham, United States Fidelity TalentSource LLC Full time

    Job Description: Position Description: Performs analysis on large data sets for system development projects using large data tools.-- Microsoft Excel, Microsoft Access, and Atlassian JIRA. Analyzes data and ensures systems are functioning according to detailed business requirements using Project and Portfolio Management (PPM) methodologies. Designs core...

  • Senior Business Analyst

    1 month ago

    Durham, United States Fidelity TalentSource LLC Full time

    Job Description:Position Description: Performs analysis on large data sets for system development projects using large data tools.-- Microsoft Excel, Microsoft Access, and Atlassian JIRA. Analyzes data and ensures systems are functioning according to detailed business requirements using Project and Portfolio Management (PPM) methodologies. Designs core...

  • Senior Business Analyst

    3 weeks ago

    Durham, United States Fidelity TalentSource LLC Full time

    Job Description:Position Description: Performs analysis on large data sets for system development projects using large data tools.-- Microsoft Excel, Microsoft Access, and Atlassian JIRA. Analyzes data and ensures systems are functioning according to detailed business requirements using Project and Portfolio Management (PPM) methodologies. Designs core...

  • Head of Site Engineering

    3 weeks ago

    Durham, United States Biogen Full time

    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 a team of highly technical professionals managing & executing activities in...

  • Junior Software Engineer

    2 days ago

    Durham, United States Computer Task Group Full time

    Description: Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 15 years! Apply with CTG for this exciting opportunity! CTG's premier client has a contract assignment for a Junior Software Engineer . Type: Contract Location: Durham, NC *Candidates must be able to commute and work onsite in...