CSV Engineer

2 months ago

Durham, United States Verista Full time
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 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

  • Senior Software Quality Engineer

    5 days 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...

  • Integration Engineer

    3 weeks 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...

  • Integration Engineer

    1 day 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

    4 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

    3 weeks 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

    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 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...

  • Logistics OTM Functional Team Lead

    2 weeks ago

    Durham, United States Cisco Full time

    WHAT YOU'LL DO As an Oracle Transportation Management, (OTM) Functional Lead on the Logistics Transformation & Execution team, you will be designing, implementing, configuring, and operating functions that support Logistics Operations in the OTM application. Core operational processes for Forward Logistics and Service Logistics are supported by the...

  • Logistics OTM Functional Team Lead

    5 days ago

    Durham, United States Cisco Full time

    As an Oracle Transportation Management, (OTM) Functional Lead on the Logistics Transformation & Execution team, you will be designing, implementing, configuring, and operating functions that support Logistics Operations in the OTM application. Core operational processes for Forward Logistics and Service Logistics are supported by the application. You will...