6546- Senior CSV Engineer / Senior Validation Engineer

Verista•Indianapolis, IN

About The Position

Verista is seeking a Senior Validation Engineer with deep computer system validation (CSV) experience to design and carry out validation activities independently in accordance with applicable regulations and quality requirements. The role provides technical guidance to team members, involves direct client interaction, and may support multiple projects at once. The engineer will work with GxP computerized systems across enterprise, laboratory, and IT environments. The role requires independently producing CSV deliverables, evaluating systems and integrations, supporting quality and change-management activities, maintaining audit-ready records, and communicating requirements and recommendations to clients. It also includes mentoring less experienced colleagues and identifying potential opportunities to expand business. Verista describes itself as a life sciences services company with a people-focused, inclusive culture that emphasizes client success, ethical conduct, colleague support, and continuous learning.

Requirements

Bachelor's degree or equivalent.
Minimum of 4–6 years of CSV-specific validation experience in the pharmaceutical, biotechnology, or medical device industry.
Track record of independently producing CSV deliverables in a cGxP-regulated environment.
Strong knowledge of cGMPs, Good Documentation Practices, and regulatory expectations for computerized systems, such as 21 CFR Part 11, EU Annex 11, and GAMP 5.
Hands-on experience with system design and/or configuration.
Familiarity with business processes in areas such as R&D, Clinical, Quality Systems, Supply Chain, or Commercialization.
Advanced Microsoft Word, Excel, and PowerPoint skills.
Intermediate Microsoft Project skills.
Professional maturity, strong interpersonal skills, and good judgment, including the ability to set priorities and make sound decisions independently.
Strong problem-solving skills, attention to detail, and organization.

Nice To Haves

Experience with laboratory systems such as LIMS, Empower/CDS, HPLC, and GC.
Digital Validation experience.

Responsibilities

Design validation plans and strategies for GxP computerized systems, including enterprise, laboratory, and IT systems.
Author, review, and execute CSV deliverables, including impact and risk assessments, requirements and specifications, test protocols, and summary reports.
Conduct impact and risk assessments, understand system functionality, and classify systems and functions as direct, indirect, or no impact.
Independently verify testing against specifications and recommend design or process changes based on test results.
Work with client quality representatives on deviation investigations, root cause analysis, and resolution.
Support client change-management programs by authoring proposed changes, conducting impact and regression assessments, and documenting change results and releases.
Evaluate system integrations, including their design and construction, data flows between source and target systems, and appropriate testing.
Maintain clear, detailed, audit-ready records of qualification, validation, and change-control activities, and ensure the team does the same.
Mentor and guide less experienced team members.
Communicate requirements and their rationale clearly, in writing and in person, to all levels of the client organization.
Identify opportunities to expand the business and refer them to management for follow-up.