Senior CSV Engineer

Creative Solutions Services, LLC; Boulder (CO); On-site; USD 125,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior CSV Engineer to lead validation for GxP systems (LIMS, MES, ERP, ELN). You will ensure compliance with FDA/EU regulations and guide validation strategy across the system lifecycle.

You will mentor junior engineers, drive risk-based validation, and collaborate with IT, QA, and business teams to ensure compliant deployment and data integrity.

Qualifications

• 5–10+ years in Computer System Validation (CSV) or validation engineering.
• Experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
• Authoring and executing IQ/OQ/PQ protocols and validation documentation.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Experience supporting regulatory audits and inspections.

Responsibilities

• Lead and execute CSV activities for GxP-regulated systems.
• Develop and review validation deliverables (URS, IQ/OQ/PQ, protocols, reports).
• Ensure compliance with FDA and EU regulations.
• Define and implement risk-based validation strategies.
• Oversee validation of LIMS, ELN, MES, ERP, CDS, and lab systems.
• Support system implementations, upgrades, and decommissioning from a validation perspective.
• Collaborate with IT, QA, Engineering, and business stakeholders.
• Lead change control assessments and determine validation impact.
• Ensure data integrity (ALCOA+) across validated systems.
• Support audits and regulatory inspections with validation documentation.
• Mentor and guide junior CSV engineers and validation staff.
• Drive continuous improvement of validation processes and templates.
• Review vendor documentation to meet regulatory expectations.

Skills

GxP compliance

Regulatory knowledge

Risk-based validation

Leadership

Quality documentation

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences

Tools

LIMS

MES

ERP systems

LabWare

Job description

Job Description:

The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

Responsibilities:

• Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
• Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
• Define and implement risk-based validation strategies for computerized systems.
• Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
• Support system implementations, upgrades, and decommissioning activities from a validation perspective.
• Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
• Lead change control assessments and determine validation impact of system changes.
• Ensure data integrity (ALCOA+) compliance across validated systems.
• Support audits and regulatory inspections by providing validation documentation and system justification.
• Mentor and guide junior CSV engineers and validation team members.
• Drive continuous improvement of validation processes, templates, and standards.
• Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.

Requirements:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 5–10+ years of experience in Computer System Validation (CSV) or validation engineering.
• Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
• Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
• Strong understanding of risk-based validation and data integrity principles.
• Experience supporting regulatory audits and inspections.

Preferred Skills:

• Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower.
• Knowledge of cloud-based validation and SaaS systems.
• Experience in data integrity remediation projects.
• Strong technical writing and documentation skills.
• Ability to lead cross-functional validation projects.

Key Competencies:

• Strong leadership and SME-level expertise in CSV.
• Excellent analytical and risk assessment skills.
• Strong communication and stakeholder management.
• Ability to manage multiple validation projects simultaneously.
• High attention to detail and regulatory compliance mindset.