Onsite CSV/CQV Engineer — Biopharma Validation Pro

Fusion Life Sciences; Massachusetts; On-site; USD 83,000 - 152,000; Full time

Job summary

Fusion Life Sciences is seeking an experienced CSV/CQV Engineer to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. The primary focus is Computer System Validation, with CQV activities as project priorities.

Ideal candidates will have 6+ years of GMP validation experience, strong CSV lifecycle knowledge, and the ability to collaborate cross-functionally with Quality, Engineering, Manufacturing, and IT in a fast-moving project setting.

Qualifications

• Approximately 5–10 years of validation experience in GMP-regulated environments.
• Strong CSV validation experience.
• Experience validating GMP computerized systems.
• Knowledge of the CSV lifecycle including validation planning, requirements, risk assessment, testing, traceability, and documentation.
• Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.

Responsibilities

• Provide onsite validation support for CSV in a regulated biopharmaceutical manufacturing environment.
• Validate computerized systems against GMP requirements and document results.
• Execute approved validation protocols and investigate discrepancies.
• Support CQV activities and collaborate with cross-functional teams.

Skills

Validation experience

CSV lifecycle

Data integrity

Cross-functional collaboration

GMP systems

Job description

Fusion Life Sciences is seeking an experienced CSV/CQV Engineer to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. The primary focus is Computer System Validation, with CQV activities as project priorities.

Ideal candidates will have 6+ years of GMP validation experience, strong CSV lifecycle knowledge, and the ability to collaborate cross-functionally with Quality, Engineering, Manufacturing, and IT in a fast-moving project setting.