Senior CSV Engineer — GMP Validation Lead

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

Benefits offered by this job

Competitive pay

Health insurance

Tuition reimbursement

Paid time off

Life Insurance

Job summary

Verista, Inc. in Devens, MA is seeking a Senior CSV/CSA Engineer to lead validation of standalone bioprocess equipment using UNICORN, KlariFi and Lucullus software, not integrated with DeltaV.

You will own the CSV lifecycle and coordinate with Process Engineering, CQV, Automation, Quality, IT and vendors. You will develop validation plans, assess architecture, review specifications, and execute risk-based test protocols while ensuring 21 CFR Part 11 and EU Annex 11 compliance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science or related field.
• 7+ years of CSV/CSA or computerized validation experience in regulated life sciences.
• Hands-on validation of standalone GMP equipment; familiarity with 21 CFR Part 11 and EU Annex 11.
• Experience with validation lifecycle documents and risk-based testing.
• Ability to coordinate with vendors, CQV, QA and process engineers.

Responsibilities

• Lead CSV/CSA strategy for standalone GMP equipment systems.
• Review architecture, URS, functional specs and design docs for GxP impact.
• Create and approve validation plans, risk assessments and supplier assessments.
• Develop risk-based test protocols and assess vendor FAT/SAT/IQ/OQ documents.
• Manage traceability, deviations, CAPAs and validation reporting.
• Support change control, SOPs, training and system release.

Skills

CSV validation

Regulated environment

Documentation

Risk-based testing

Vendor coordination

21 CFR Part 11

GAMP 5

UNICORN/KlariFi/Lucullus

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science

Tools

UNICORN

KlariFi

Lucullus

Kneat

Job description

Verista, Inc. in Devens, MA is seeking a Senior CSV/CSA Engineer to lead validation of standalone bioprocess equipment using UNICORN, KlariFi and Lucullus software, not integrated with DeltaV.

You will own the CSV lifecycle and coordinate with Process Engineering, CQV, Automation, Quality, IT and vendors. You will develop validation plans, assess architecture, review specifications, and execute risk-based test protocols while ensuring 21 CFR Part 11 and EU Annex 11 compliance.