6490 - Senior CSV Engineer / Senior Validation Engineer

Verista; Harvard (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive pay

401(k) Retirement Plan (Employer Match

Paid Time Off

Health Insurance

Tuition Reimbursement

Job summary

Verista is seeking a Senior Validation Engineer to support UAT scope, create test scripts, and manage evidence collection and defect tracking. You will draft SOPs, ensure documentation follows client and regulatory standards, and coordinate with global QA and IT teams.

This remote role may require limited travel to client sites with advance notice. The ideal candidate has 5+ years in regulated life sciences validation, hands-on UAT experience, and familiarity with Kneat, HP ALM, Jira, and

Qualifications

• Bachelors Degree in industry-related discipline.
• 5+ years supporting regulated life sciences systems or similar projects.
• Hands-on with UAT, test scripts, and validated documents.
• Experience with GMP/CSV/validation practices and document control.

Responsibilities

• Support UAT scope and test script development based on requirements.
• Coordinate UAT execution, scheduling, evidence collection and defect tracking.
• Draft and update SOPs and templates to client standards.
• Format documents per Good Documentation Practices.
• Assist with translation-package preparation for multilingual content.
• Coordinate with global QA, IT, and site teams.

Skills

Regulatory experience

UAT / test-script development

Stakeholder coordination

Documentation quality

Communication skills

Education

Bachelor's Degree in discipline

Tools

Kneat

HP ALM/Quality Center

Jira

Veeva Vault

Documentum

Job 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 decisionmaking 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

Senior Validation Engineer Responsibilities:

• Support development of UAT scope, test scenarios, and test scripts based on approved requirements and business processes
• Coordinate and support UAT execution, tester scheduling, evidence collection, defect tracking, retesting, traceability, and closure
• Draft and update SOPs, work instructions, job aids, templates, commissioning documents, and global procedure revisions
• Format documents according to client standards and Good Documentation Practices
• Route documents through the client's electronic document management system and support review and approval workflows
• Support digitization of document and template libraries, including formatting, metadata, traceability fields, and document tracking
• Develop and format training materials, quick-reference content, and user communications
• Support change-control activities, adoption materials, and implementation action tracking
• Maintain deployment-readiness trackers covering user access, training completion, readiness checklists, cutover inputs, and open actions
• Support go-live and hypercare activities, including issue logging, routing, follow-up, and resolution tracking
• Assist with translation-package preparation and review coordination for Portuguese, Japanese, and Spanish content
• Coordinate with global C&Q representatives, subject matter experts, Quality, IT, site teams, and external vendors
• Provide clear progress, issue, risk, and action updates

Requirements:

• Bachelors Degree in industry-related discipline
• 5+ years of experience supporting regulated life sciences systems, validation, quality, engineering, or digital transformation projects
• Kneat Power User Level 1 (or higher) certification highly preferred
• Hands-on experience with UAT, test-script development, regulated documentation, or system deployment activities
• Working knowledge of GxP, CSV, CSA, validation, or regulated system implementation practices
• Experience authoring or revising SOPs, work instructions, test scripts, job aids, templates, or other controlled documentation
• Familiarity with requirements traceability, test evidence, defect management, document workflows, or deployment-readiness tracking
• Strong writing, organization, communication, and stakeholder-coordination skills
• Ability to manage multiple priorities and work independently within a global, cross-functional team
• Experience with digital C&Q, validation, quality, engineering, or manufacturing platforms preferred
• Experience with Kneat or a comparable digital validation solution preferred
• Experience with HP ALM/Quality Center, Jira, or another test-management platform preferred
• Experience with BMSDocs, Documentum, Veeva Vault, or another electronic document management system preferred
• Experience supporting enterprise or multi-site deployments preferred
• Familiarity with change control, training-readiness tracking, go-live, and hypercare preferred
• Experience coordinating translation packages or multilingual document updates. preferred
• This role is remote; limited travel to client site may be requested with advance notice

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.

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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

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