Sr Engineer Computer Systems 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

Position Summary

The Senior Engineer, IT Compliance and CSV supports computerized system validation, IT compliance, and change/deviation management for regulated computerized systems across the Devens Campus (including the Cell Therapy Facility). Executes System Life Cycle deliverables; serves as a CSV SME; supports IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs; works with Quality, Validation, Manufacturing, Engineering, and enterprise teams.

Duties/Responsibilities

• Execute CSV and IT compliance activities (including for Devens CTF) aligned to team/site objectives.
• Serve as CSV SME for computerized system changes and related IT/Automation projects; advise operations.
• Support IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs.
• Guide Digital Plant/site groups on CSV process implementation; analyze/address process deficiencies.
• Support Data Integrity and Quality Risk Management programs.
• Provide IT quality support: review/approve investigations and change controls; own computerized system events and CSV activities.
• Enter/support deviations, actions, root cause analysis, CAPA, and effectiveness reviews in the Quality Management System.
• Participate in regulatory/internal audits and inspections; respond to audit observations.
• Implement/track Service Level Agreements (SLAs) for business-critical activities.
• Develop/maintain GxP procedures and guidance for compliance and audit readiness.
• Execute validation/implementation/change management for regulated IT systems.
• Track project progress; provide updates via tools/dashboards.
• Improve efficiency/quality of CSV documentation and processes; evaluate technologies/tools/process improvements.

Qualifications

• Bachelor’s degree (Engineering/Science/IT or related IT/OT), 3–5 years relevant Compliance and CSV experience (preferably Cell Therapy/Biologics Manufacturing).
• Knowledge of regulatory CSV requirements (FDA/EMA; e.g., ICH Q7/Q8/Q9).
• Working knowledge: 21 CFR Part 11; 21 CFR Parts 210/211; GAMP (ISO 9001 is a plus).
• Working knowledge of health authority/digital asset requirements incl. Data Integrity.
• Experience with quality systems, risk management, audit readiness, deviation and change management in regulated automated manufacturing.
• Ability to represent department to stakeholders and regulatory agencies.
• Ability to support US FDA and other agency interactions.
• Strong project management, communication, and technical writing; training experience is a plus.
• Lean Six Sigma and OPEX understanding.
• Ability to innovate, synthesize cross-functional solutions, collaborate, and manage multiple priorities.
• Internal audit/inspection experience advantageous.
• Willingness to mentor and share knowledge.

Compensation/Benefits

• Devens, MA: $99,480–$120,551 (full-time). Additional incentive cash/stock may be available (eligibility-based).
• Benefits include health coverage, wellbeing support, and financial protection; work-life benefits include Paid Time Off (specific to role/location).