CSV Engineer - Durham, United States - Verista

    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.


    Please make an application promptly if you are a good match for this role due to high levels of interest.


    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.