Senior CSV/CSA Engineer – On-Site Validation Lead

Veristainc; Harvard (MA); On-site; USD 80,000 - 132,000; Full time

Benefits offered by this job

401(k) Retirement Plan (Employer Match

Tuition Reimbursement

Paid Time Off—Holidays

Job summary

Verista is seeking a Senior CSV/CSA Engineer to lead validation activities for standalone bioprocess equipment in a Devens, MA facility. You will own the CSV lifecycle, coordinate with CQV, QA, IT, and vendors, and ensure compliance with 21 CFR Part 11 and EU Annex 11.

The role requires a Bachelor’s degree in Engineering/Life Sciences/CS and 7+ years of validation experience, with hands-on work validating standalone GMP manufacturing equipment and a strong grasp of data-integrity concepts.

Qualifications

• Seven+ years of CSV/CSA or computerized-equipment validation experience in a regulated life-sciences environment.
• Hands-on experience validating standalone GMP manufacturing equipment.
• Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5 and data-integrity principles.
• Experience validating access security, audit trails, electronic signatures, and electronic records.
• Ability to review functional specifications, configuration specifications and system architecture.

Responsibilities

• Develop and execute the CSV/CSA strategy for standalone GMP equipment systems.
• Review equipment and software architecture, intended use and GxP impact.
• Author or review validation plans, system assessments, risk assessments and supplier assessments.
• Review URS, functional specifications, configuration specifications and design documentation.
• Develop and execute risk-based test protocols.
• Evaluate vendor FAT, SAT, IQ and OQ documentation for leveraged testing.
• Test user access, roles, permissions and account administration.
• Test audit trails, electronic records and electronic signatures.
• Verify recipe, method and configuration controls.
• Test alarms, events, reports, data capture and record retention.
• Verify backup, restoration, archival, time synchronization and disaster-recovery controls.
• Assess compliance with 21 CFR Part 11, EU Annex 11 and applicable data-integrity requirements.
• Maintain requirements traceability and validation-documentation packages.
• Manage discrepancies, deviations, corrective actions and validation-summary reporting.
• Support change control, SOP development, training and system release.

Skills

CSV/CSA validation

GxP

21 CFR Part 11

SOPs and validation documentation

Independent work with vendors

Education

Bachelor’s degree in Engineering/Life Sciences/Computer Science

Tools

UNICORN

KlariFi

Lucullus

Kneat

Job description

Verista is seeking a Senior CSV/CSA Engineer to lead validation activities for standalone bioprocess equipment in a Devens, MA facility. You will own the CSV lifecycle, coordinate with CQV, QA, IT, and vendors, and ensure compliance with 21 CFR Part 11 and EU Annex 11.

The role requires a Bachelor’s degree in Engineering/Life Sciences/CS and 7+ years of validation experience, with hands-on work validating standalone GMP manufacturing equipment and a strong grasp of data-integrity concepts.