Senior CSV Engineer – Standalone GMP Validation Lead

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

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Verista is seeking a Senior CSV/CSA Engineer to lead validation activities for standalone bioprocess equipment at a single-use manufacturing site in Devens, MA. The role coordinates with Process Engineering, CQV, Automation, Quality, IT, vendors and system owners to own the validation lifecycle.

The ideal candidate has 7+ years in CSV/CSA in regulated life sciences, with hands-on validation of standalone GMP equipment and expertise in 21 CFR Part 11/EU Annex 11. On-site work required.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or Computer Science.
• 7+ years of CSV/CSA or computerized equipment validation in life sciences.
• Hands-on validation of standalone GMP equipment.
• Strong understanding of 21 CFR Part 11 and EU Annex 11.
• Experience reviewing URS, FS, and design docs.
• Familiar with UNICORN, KlariFi or Lucullus.

Responsibilities

• Develop and execute the CSV/CSA strategy for standalone GMP equipment.
• Review equipment/software architecture and GxP impact.
• Author validation plans, risk assessments and supplier assessments.
• Review URS, FS, configuration specs and design docs.
• Develop and execute risk-based test protocols.
• Evaluate vendor FAT, SAT, IQ and OQ documentation.
• Test user access, roles, permissions and account administration.
• Test audit trails, electronic records and electronic signatures.
• Maintain 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 expertise

Regulated life sciences

Vendor coordination

Documentation & audits

Risk assessment

Test protocol development

On-site work

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

UNICORN

KlariFi

Lucullus

Kneat

Job description

Verista is seeking a Senior CSV/CSA Engineer to lead validation activities for standalone bioprocess equipment at a single-use manufacturing site in Devens, MA. The role coordinates with Process Engineering, CQV, Automation, Quality, IT, vendors and system owners to own the validation lifecycle.

The ideal candidate has 7+ years in CSV/CSA in regulated life sciences, with hands-on validation of standalone GMP equipment and expertise in 21 CFR Part 11/EU Annex 11. On-site work required.