Senior CSV Engineer — Regulated Systems Validation Leader

Katalyst-Healthcares-; St. Louis (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Senior CSV Engineer to lead validation of GxP-regulated systems, including LIMS, MES, ERP, and ELN. You will define risk-based strategies, author validation documentation, and ensure data integrity across validated systems.

The role requires strong leadership, collaboration with IT, QA, engineering, and business stakeholders, and experience supporting regulatory audits and inspections.

Qualifications

• Requires 5–10+ years of CSV or validation engineering experience.
• Experience in GxP-regulated pharma/biotech/medical device environments.
• Experience authoring IQ/OQ/PQ protocols and validation documentation.
• Strong knowledge of data integrity and 21 CFR Part 11.

Responsibilities

• Lead CSV activities for GxP-regulated systems.
• Develop and review validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ.
• Ensure compliance with FDA/EU/GAMP 5 and GxP regs.
• Define risk-based validation strategies and oversee system validation.
• Mentor junior CSV engineers and coordinate cross-functional teams.
• Support audits, vendor documentation, and validation lifecycle.

Skills

CSV expertise

Regulatory compliance

Leadership

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field

Tools

LabWare

SAP

Oracle

Veeva

TrackWise

Empower

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.