CSV Engineer

3 weeks ago


Durham, United States CareerBuilder 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

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