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Verista

GxP lifecycle consulting for life sciences

Senior CSV Engineer / Senior Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeIndianapolis, IN, USAIn-person

About the Job

Requirements

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

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 based on a full understanding of system operation, 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 the client's change management program by authoring proposed changes, conducting impact and regression assessments, and documenting change results and release.
  • Evaluate system integrations, including how they are designed and built, how data flows from source to target systems, and how to test them.
  • Maintain clear, detailed records of qualification, validation, and change control activities for future audits, and ensure the team does the same.
  • Mentor and guide less experienced team members.
  • Communicate requirements and the reasoning behind them clearly in writing and in person to all levels of the client's organization.
  • Identify opportunities to expand the business and pass them to management for follow-up.

Desired Qualifications

  • Experience with laboratory systems such as LIMS, Empower/CDS, HPLC, and GC is a plus.
  • Digital Validation experience is preferred.

About the Company

Verista

GxP lifecycle consulting for life sciences

Verista provides business and technology consulting for life science companies, focusing on systems, compliance, validation and quality across the GxP lifecycle. Its services cover preclinical, clinical, commercialization, manufacturing and distribution to ensure safe, high-quality results. The company combines decades of industry knowledge with advanced engagement platforms and transformative technologies to help clients solve complex challenges with one partner across specialties. With a team of 500+ experts, Verista supports clients from strategy and validation to execution, delivering consistent, compliant outcomes that improve health and lives. The goal is to enable better health outcomes by ensuring products and processes are safe, compliant and efficient throughout the product development lifecycle.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
Fishers, IN
Founded
2020

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