Senior CSV Engineer — Lead GMP Equipment Validation

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

Benefits offered by this job

Competitive pay

Health, Dental & Vision

401(k) Matching

Tuition Reimbursement

Paid Time Off

Job summary

Verista in Devens, MA is seeking a Senior CSV/CSA Engineer to lead validation activities for standalone GMP equipment using UNICORN, KlariFi and Lucullus. You will own the CSV lifecycle and coordinate with Process Engineering, CQV, Automation, Quality, IT, vendors and system owners.

This on-site, full-time role requires a bachelor’s in engineering or life sciences, 7+ years in validation, and strong knowledge of 21 CFR Part 11, EU Annex 11 and data integrity.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science or related discipline.
• 7+ years of CSV/CSA or computerized-equipment validation experience in regulated life-sciences environment.
• Hands-on experience validating standalone GMP manufacturing equipment.

Responsibilities

• Develop and execute CSV/CSA strategy for standalone GMP equipment systems.
• Review equipment/software architecture and GxP impact.
• Author or review validation plans, risk assessments and supplier assessments.
• Review URS, functional and configuration specifications, and design docs.
• Develop and execute risk-based test protocols.
• Evaluate vendor FAT/SAT/IQ/OQ documentation for testing.
• Test user access, audit trails and electronic signatures.
• Verify backup, restoration, archival, time synchronization controls.
• Maintain requirements traceability and validation documentation.

Skills

CSV/CSA validation

Regulatory compliance

Protocol writing

Vendor management

Independent work

Risk assessment

21 CFR Part 11 knowledge

GAMP 5 knowledge

Data integrity

Education

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

Tools

UNICORN

KlariFi

Lucullus

Kneat

Job description

Verista in Devens, MA is seeking a Senior CSV/CSA Engineer to lead validation activities for standalone GMP equipment using UNICORN, KlariFi and Lucullus. You will own the CSV lifecycle and coordinate with Process Engineering, CQV, Automation, Quality, IT, vendors and system owners.

This on-site, full-time role requires a bachelor’s in engineering or life sciences, 7+ years in validation, and strong knowledge of 21 CFR Part 11, EU Annex 11 and data integrity.