Csv Engineer/Analyst - Senior Validation Engineer - 4844

Verista’s600 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:
Review 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
Additional Potential Responsibilities
Provide IT CSV support to implement and validate electronic systems in accordance with corporate policies and procedures
Collaborate to gather business needs and utilize appropriate tool for tracking of the work allocated
Provide regular reporting of project timelines, issues/escalations and other metrics/KPIs
Work directly with the business, validation team and other stakeholder groups for implementation, operational and development changes for the given systems
Assist in the review of change controls and associated tasks. Effectively assist to project manage projects to completion
Review and provide feedback/approval on risk assessments, Validation Plans, Specifications, Test scripts, Installations Qualification Protocols, Operational Qualification Protocols, Performance Qualifications Protocols, Trace Matrices and Summary Reports associated with validated computer systems
Engage in Quality process improvement initiatives, as applicable
Review and approval of defined life cycle deliverables in compliance with the governing regulations and procedures.
Perform supporting quality related activities associated with computerized systems including review of change controls and test runs when applicable
Provide guidance to project teams on compliance requirements for the given project as it relates to activities within scope
Perform all assigned and required trainings to maintain 100% compliance
Requirements
Must be willing to work onsite in either Durham, NC or Elkton, VA
Must have CSV QA experience, with the ideal candidate having performed the final QA signature on the entire SDLC documentation suite
Delta V experience
Strong Data Integrity knowledge;
knowledge of principles, how to apply them, and how to improve and implement data integrity
Proficiency using PC and Microsoft Office tools
Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
Ability to work as part of a team
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Experience in GMP regulated environment
Proven attention to detail and organization in project work
Capable of working on assigned tasks without mentorship
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.
$70,941 - $(phone number removed)
*Verista is an equal opportunity employer.