6546- Senior CSV Engineer / Senior Validation Engineer

Verista; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive pay

401(k) Retirement Plan (Employer Match

Paid Time Off and Holidays

Medical, Dental & Vision

Tuition Reimbursement

Life, Disability Insurance

Employee Recognition

Parental Leave

Job summary

Verista is seeking a Senior Validation Engineer with deep CSV experience to design and execute validation activities on GxP computerized systems. You will provide technical guidance, work directly with clients, and potentially support multiple projects.

You will lead validation planning, perform impact and risk assessments, write and review validation deliverables, and ensure robust documentation for audits. Collaboration with client teams and mentorship of colleagues are key aspects of the role.

Qualifications

• Bachelor's degree or equivalent.
• 4-6 years of CSV-specific validation in pharma/biotech/medical device.
• Track record delivering CSV deliverables independently in a cGxP environment.
• Strong knowledge of cGMPs, DOP, and regulatory expectations for computerized systems (21 CFR Part 11, EU Annex 11, GAMP 5).
• Hands-on system design/configuration experience; familiarity with R&D, Clinical, Quality Systems, Supply Chain or Commercialization processes.
• Lab systems experience (LIMS, Empower/CDS, HPLC, GC) is a plus.
• Advanced MS Word, Excel, PowerPoint; Intermediate MS Project.
• Professional maturity, strong interpersonal skills, good judgment, independent prioritization.
• Digital Validation experience preferred.

Responsibilities

• Design validation plans and strategies for GxP systems.
• Author, review, and execute CSV deliverables and reports.
• Run impact and risk assessments and classify system impact.
• Independently verify testing and recommend design changes.
• Coordinate with client quality for deviation investigations and root cause analysis.
• Support change management with impact assessments and release documentation.
• Evaluate system integrations and data flows for testing.
• Maintain detailed records for audits and guide the team.
• Mentor less experienced team members.
• Communicate requirements clearly to all client levels.
• Spot opportunities to expand business.

Skills

CSV validation

Regulatory knowledge

Validation planning

Mentoring

Client interaction

MS Office

Analytical thinking

Education

Bachelor's degree

Tools

LIMS

Empower/CDS

HPLC

GC

MS Project

GxP validation software

Job description

Description

Description Verista’s 500 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

The Role

We're looking for a Senior Validation Engineer with deep CSV experience. You'll design and carry out validation activities on your own, in line with regulations and quality requirements. You'll give technical guidance to other team members, work directly with clients, and potentially support more than one project at a time.

What You'll Do

• Design validation plans and strategies for GxP computerized systems, including enterprise, lab, and IT systems
• Author, review, and execute CSV deliverables, including impact and risk assessments, requirements and specifications, test protocols, and summary reports
• Run impact and risk assessments with a full understanding of how the system works, and classify systems and functions as direct, indirect, or no impact
• Independently verify testing against specifications, and make recommendations for design or process changes based on test results
• Work with the client's quality representatives on deviation investigations, root cause analysis, and resolution
• Support the client's change management program by authoring proposed changes, running impact and regression assessments, and documenting change results and release
• Evaluate system integrations: how they're designed and built, how data flows from source to target systems, and how to test them
• Keep clear, detailed records of qualification, validation, and change control activities so they're ready for future audits, and make sure the team does the same
• Mentor and guide less experienced team members
• Communicate requirements, with the reasoning behind them, clearly in writing and in person to all levels of the client's organization
• Spot opportunities to expand the business and pass them to management for follow-up

What You Bring

• Bachelor's degree or equivalent
• MINIMUM of 4-6 years of CSV specific validation experience in the pharmaceutical, biotech, or medical device industry
• A track record of producing CSV deliverables independently 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, and familiarity with business processes in areas such as R&D, Clinical, Quality Systems, Supply Chain, or Commercialization
• Experience with lab systems (LIMS, Empower/CDS, HPLC, GC) is a plus
• Advanced Microsoft Word, Excel, and PowerPoint skills. Intermediate Microsoft Project skills
• Professional maturity, strong interpersonal skills, and good judgment. You can set your own priorities and make sound decisions on your own
• Strong problem-solving skills, attention to detail, and organization
• Digital Validation experience preferred

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.

National (US) Range: $70,491 USD - $110,000 USD

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

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For more information about our company, please visit us at Verista.com