6490 - Senior CSV Engineer / Senior Validation Engineer New Devens, MA (Remote)

Verista; Northern (KY); Hybrid; USD 79,000 - 114,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Paid time off

Life insurance

Job summary

Verista is seeking a skilled UAT and validation specialist to support regulated life sciences projects. You will assist with test-script development, evidence collection, and go-live activities, while coordinating with global CQ/QA teams.

The role emphasizes documentation control, SOP creation, and translation coordination in a remote work setup with occasional travel to client sites.

Qualifications

• Bachelors Degree in industry-related discipline.
• 5+ years in regulated life sciences systems, validation, quality, or digital transformation.
• Kneat Power User Level 1 or higher certification highly preferred.
• Hands-on UAT, test-script development, regulated documentation, or system deployment experience.
• Knowledge of GxP, CSV, and validated system practices.
• Experience authoring or revising SOPs, test scripts, templates, or controlled docs.
• Familiarity with requirements traceability, test evidence, and deployment readiness tracking.
• Strong writing, organizational, and stakeholder coordination skills.
• Ability to work independently within a global team.
• Experience with digital C&Q, validation, quality, or manufacturing platforms.

Responsibilities

• Support UAT activities, test-script development, and evidence collection.
• Coordinate Go-Live and hypercare activities with issue logging and resolution.
• Prepare and revise SOPs, templates, and training materials.
• Support translation packages and multilingual document updates.
• Coordinate with global CQ, QA, IT, and site teams.

Skills

UAT

Test scripts

Regulated documentation

GxP knowledge

Jira

Test management

Stakeholder coordination

Documentation workflows

Multilingual translation support

Go-live support

Education

Bachelor's Degree in industry-related discipline

Tools

HP ALM/Quality Center

Veeva Vault

BMSDocs

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 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
• 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 activitiesli>
• 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 preferably
• 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
• 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.

National (US) Range

$78,925 - $113,521 USD

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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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