CSV / CQV Engineer

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

Job Title: CSV / CQV Engineer

Location: MA

Experience:6years

Resource:2

SLA:By EOD

Duration: 6 months

Start Date: August 31 st

JOB Description:

Seeking experienced CSV / CQV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require. Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners. Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.

Qualifications:

• Approximately 5 10 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
• Strong Computer System Validation experience.
• Experience supporting validation of GMP computerized systems.
• Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
• Understanding of data integrity and GMP expectations for computerized systems.
• Equipment validation / CQV experience in addition to CSV.
• Ability to execute established validation protocols and clearly document results.
• Experience investigating and documenting validation discrepancies or execution issues.
• Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
• ValGensis is a plus