Remote Senior Validation Engineer (C&Q)

Veristainc; Harvard (MA); On-site; USD 79,000 - 114,000; Full time

Benefits offered by this job

Remote work flexibility

Competitive pay and incentives

401(k) retirement plan

Tuition reimbursement

Health, dental, and vision insurance

Job summary

Verista is seeking a Senior Validation Engineer to lead C&Q activities for GMP facilities, utilities, and manufacturing systems. You will develop and execute qualification deliverables and coordinate cross-functional field execution to ensure compliant completion and closeout across multiple sites.

The role requires hands-on C&Q experience, knowledge of GMP and ASTM E2500, and proficiency with Kneat or similar digital platforms. Remote work with limited travel may be possible.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or another related discipline.
• 5+ years in C&Q/CQV, commissioning, qualification, validation in regulated life sciences environments.
• Hands-on experience with GMP facilities, utilities, equipment, or lab systems.
• Strong working knowledge of URS, DQ, FAT/SAT, IQ/OQ/PQ, traceability and risk assessment.
• Familiarity with GMP, GEP, ASTM E2500, risk-based qualification, and Good Documentation Practices.
• Kneat Power User Level 1 or higher preferred, with hands-on Kneat or similar platforms.
• Experience authoring, reviewing, and executing QC protocols, test scripts, and qualification reports.
• Experience coordinating field execution with cross-functional stakeholders.
• Familiarity with punch-list management, deviations, change control, turnover, and closeout.
• Experience with HP ALM/Jira or similar project/test-management tools.
• Experience with electronic document management systems (e.g., Documentum, Veeva Vault).
• Experience supporting large pharma/biotech projects and multi-site C&Q programs.
• Strong communication, organization, problem-solving, and stakeholder-management skills.

Responsibilities

• Lead and support C&Q activities for GMP facilities and manufacturing systems.
• Develop and execute C&Q deliverables (URS, risk assessments, DQ, FAT/SAT, IQ/OQ/PQ).
• Coordinate protocol scheduling, field execution, test evidence collection, and closeout.
• Support risk-based qualification strategies per GMP requirements and ASTM E2500.
• Author and update C&Q documents, SOPs, and test scripts per GxP.

Skills

C&Q methodologies

GMP compliance

Documentation practices

Project coordination

Cross-functional collaboration

Kneat experience

QA/QC

Education

Bachelor’s degree in Engineering/Life Sciences

Tools

HP ALM/Quality Center

Jira

Documentum

Veeva Vault

Kneat

Job description

Verista is seeking a Senior Validation Engineer to lead C&Q activities for GMP facilities, utilities, and manufacturing systems. You will develop and execute qualification deliverables and coordinate cross-functional field execution to ensure compliant completion and closeout across multiple sites.

The role requires hands-on C&Q experience, knowledge of GMP and ASTM E2500, and proficiency with Kneat or similar digital platforms. Remote work with limited travel may be possible.