CSV Engineer (6mo. Contract-to-Hire)
Location: Baltimore, MD
Company
Join a premier global Contract Development and Manufacturing Organization (CDMO) that is rapidly expanding its state-of-the-art sterile manufacturing footprint in Baltimore. This organization is a strategic partner to leading pharmaceutical and biotech companies, specializing in the end-to-end development and commercialization of complex injectable products. With a reputation for scientific excellence and a commitment to Quality by Design, they offer a dynamic, client-facing environment where technical experts lead the transition of life-saving therapies from the lab to commercial scale.
Job Summary
The CSV Engineer will interact with QA, IT, and business area users to generate user requirements and understand system functionality and use with respect to computerized systems and data integrity. Maintain current system functionality and use to ensure cGMP regulatory compliance. Perform periodic reviews and remediation activities for validated systems.
What You'll Do
- Possess strong knowledge of validation and related practices, including governmental regulations (e.g., 21CFR Part 11, EU Annex 11)
- Plan, coordinate, and execute assigned projects by effectively using Project Management methodologies
- Act as a subject matter expert on computer validation lifecycle processes, articulating these to clients and regulatory bodies
- Validate and qualify computerized manufacturing PLC-based and Windows-based systems in GXP environments
- Write and review validation documentation, including Validation Plans, User Requirements, IQ/OQ/PQ Protocols, and Summary Reports
- Perform global computerized system risk assessments and vendor evaluations
- Drive project execution and serve as a coach/mentor to project teams to promote continuous improvement and professional growth
- Implement Computer System Assurance (CSA) Methodologies: Lead the transition from traditional, documentation-heavy Computer System Validation (CSV) to a right-sized, risk-based CSA approach, leveraging critical thinking to focus formal testing efforts on high-risk GxP functionalities, patient safety, and data integrity.
- Qualify Standalone GxP Software from Scratch: Manage the complete end-to-end validation lifecycle for new, bespoke, or custom-built standalone software platforms (including GAMP Class 5 applications) without relying on pre-existing vendor frameworks.
- Perform Right-Sized Software Risk Assessments: Conduct strategic risk modeling and Failure Mode and Effects Analysis (FMEA) to distinguish high-risk GxP functions from low-risk features, establishing documented justifications to optimize the testing burden and avoid unnecessary verification.
- Bridge Information Technology and Automation Networks: Translate complex network architectures, server security setups, and firewall configurations into GxP-compliant validation test protocols.
- Establish Data Integrity and Digital Readiness Strategy: Drive the site's transition from legacy paper-based recording systems to electronic data acquisition and chartless recording, ensuring robust controls for audit trails, user access interfaces, and electronic records.\
- Defend and Justify Validation Scoping: Act as the strategic owner of the CSV/CSA framework, demonstrating the confidence and technical expertise to justify and defend risk-based testing strategies to cross-functional stakeholders and regulatory bodies during audits.
What You'll Bring
- Bachelor's degree required
- At least 7 years of experience in computer systems validation and 21 CFR Part 11 / Annex 11 within GMP/GLP industries
- Comprehensive knowledge of the computer validation lifecycle process
- Fluency with SAP, PLCs, and laboratory computer systems
- Proficiency in Microsoft Word, Outlook, and Excel
Work Environment & Role Demands
In this role, you will be expected to organize and coordinate complex tasks, solving issues independently using sound judgment. You should be comfortable working in a fast-paced environment with frequent interruptions. The position requires strong visual acuity and eye/hand coordination for keyboard use and traversing laboratory areas. You will primarily work on-site with minimal travel, occasionally working around extreme temperatures or noise above conversation levels. Regular and predictable attendance is essential to support our laboratory operations.