Senior CSV Engineer - IT Compliance & Validation

Scorpion Therapeutics; Harvard (MA); On-site; USD 99,000 - 121,000; Full time

Benefits offered by this job

Health coverage

Wellbeing support

Paid time off

Job summary

Scorpion Therapeutics in Devens, MA is seeking a Senior Engineer to lead CSV and IT compliance for regulated systems across the campus, including the Cell Therapy Facility. You will serve as the CSV SME, manage IT/deviation activities, and collaborate with Quality, Validation, Manufacturing, and Engineering teams.

The role requires 3–5 years in compliance/CSV, strong knowledge of FDA/EMA CSV standards, and experience with audits and risk management in a GMP environment.

Qualifications

• Bachelor’s degree in Engineering/Science/IT or related field; 3–5 years CSV/compliance experience.
• Knowledge of regulatory CSV requirements (FDA/EMA; ICH Q7/Q8/Q9).
• Working knowledge of 21 CFR Part 11; GAMP; ISO 9001 is a plus.
• Awareness of Data Integrity in health authority contexts.
• Experience with quality systems, risk management, audit readiness, deviation/change management in regulated manufacturing.

Responsibilities

• Execute CSV and IT compliance activities aligned to site objectives.
• Serve as CSV SME for computerized system changes and IT projects; advise operations.
• Support deviation management, audits, change controls, and risk programs.
• Guide digital plant groups on CSV implementation and address deficiencies.
• Enter deviations, CAPA, root cause analysis, and effectiveness reviews in the QMS.
• Participate in regulatory/internal audits; respond to audit findings.
• Develop/maintain GxP procedures and audit-ready guidance.
• Track project progress and provide dashboard updates.
• Improve CSV documentation quality and process efficiency.

Skills

CSV Experience

Regulated Manufacturing

FDA/EMA Knowledge

21 CFR Part 11

GAMP

Data Integrity

Quality Systems

Risk Management

Project Management

Regulatory Audits

Education

Bachelor’s degree in Engineering/Science/IT

Job description

Scorpion Therapeutics in Devens, MA is seeking a Senior Engineer to lead CSV and IT compliance for regulated systems across the campus, including the Cell Therapy Facility. You will serve as the CSV SME, manage IT/deviation activities, and collaborate with Quality, Validation, Manufacturing, and Engineering teams.

The role requires 3–5 years in compliance/CSV, strong knowledge of FDA/EMA CSV standards, and experience with audits and risk management in a GMP environment.