GxP Validation Engineer — Instrument & CS Systems

WHITE COLLAR TECHNOLOGIES INC; Cambridge (MA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision benefits

Job summary

White Collar Technologies seeks a Validation Specialist to support QC Analytical such that CGMP status is maintained for instrumentation hardware and software. You will drive remediation initiatives, author CAPAs and final reports, and revise SOPs as needed.

The role requires hands-on validation expertise in biotech/pharma environments, plus CFR Part 11 and data integrity knowledge. This fast-moving, small company offers a collaborative atmosphere and opportunities to mentor others.

Qualifications

• Validation experience in biotech/pharma environments.
• GxP compliance and data integrity knowledge.
• Understanding of CFR Part 11 Electronic Records and Signatures.

Responsibilities

• Support QC Analytical for CGMP status of instrumentation hardware/software.
• Author CAPAs and final reports for remediation activities.
• Revise SOPs related to remediation work.
• Execute change controls and validation test plans per remediation plans.
• Develop and execute validation-related deliverables and reports.

Skills

Validation in biotech/pharma

GxP compliance

CFR Part 11 knowledge

Education

Bachelor's Degree in Engineering, Life Science or Computer Science

Job description

White Collar Technologies seeks a Validation Specialist to support QC Analytical such that CGMP status is maintained for instrumentation hardware and software. You will drive remediation initiatives, author CAPAs and final reports, and revise SOPs as needed.

The role requires hands-on validation expertise in biotech/pharma environments, plus CFR Part 11 and data integrity knowledge. This fast-moving, small company offers a collaborative atmosphere and opportunities to mentor others.