GxP Validation Engineer/Analyst — Instrument & CSV Expert

Begell House Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

Job summary

White Collar Technologies is seeking a Validation Specialist to support QC instrumentation validation and CGMP maintenance. The role includes authoring CAPAs, remediation SOPs, and driving validation deliverables across multi-disciplinary teams.

Qualifications include a biotech/pharma background with Instrument or CSV validation experience and a Bachelor's degree in engineering, life sciences, or computer science. Knowledge of GAMP and CFR Part 11 is essential.

Qualifications

• Validation experience in biotech/pharmaceutical environments, specializing in Instrument or Computer System Validation.
• Excellent working knowledge of process automation and CSV concepts, CFR Part 11 Electronic Records and Signatures, data integrity expectations.

Responsibilities

• Provide validation support for QC Instrumentation hardware/software to maintain CGMP status.
• Author and maintain Validation Plans and CAPAs; drive remediation activities and SOP revisions.
• Lead deviations resolution during protocols and approve vendor documentation.
• Develop and execute deliverables such as Risk Assessments, Validation Plans, IQ/OQ/PQ protocols and Summary Reports.

Skills

Validation expertise

GxP compliance

Mentoring

Education

Bachelor's degree in engineering/life sciences/computer science

Tools

GAMP

Job description

White Collar Technologies is seeking a Validation Specialist to support QC instrumentation validation and CGMP maintenance. The role includes authoring CAPAs, remediation SOPs, and driving validation deliverables across multi-disciplinary teams.

Qualifications include a biotech/pharma background with Instrument or CSV validation experience and a Bachelor's degree in engineering, life sciences, or computer science. Knowledge of GAMP and CFR Part 11 is essential.