Computerized System Validation Engineer II

Meso Scale Diagnostics, Llc. • Rockville, MD

128d • $78,100 - $116,200 • Hybrid

About The Position

This position is responsible for providing quality assurance that software used to support MSD manufacturing processes, analytical services, and quality management systems is validated, operated, and decommissioned in compliance with MSD policies and procedures and applicable GxP regulations. The incumbent is expected to lead validation activities for assigned projects and perform a variety of tasks supporting the validation program while working closely within project teams, often under deadlines.

Requirements

• Bachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted.
• Minimum of 3 years of experience in computerized systems validation in a relevant industry (e.g., in vitro diagnostics, medical device, biotech, pharmaceutical, regulated bioanalysis).
• Experience with quality management systems compliant to ISO 9001 and ISO 13485 strongly preferred.
• Experience with validating computerized systems in a GLP/GCLP environment strongly preferred.

Nice To Haves

• Knowledge of working in a regulated environment and standard industry validation practices is required.
• Knowledge of Good Automated Manufacturing Practice (GAMP) guidelines, computerized system validation principles and best practices is required.
• Working knowledge of 21 CFR Part 11 requirements and data integrity principles, including technical and procedural controls.
• Working knowledge of 21 CFR Part 58 (GLP) and Good Clinical Laboratory Practice.
• Ability to interpret regulatory requirements and apply them to system implementation and validation.
• Fundamental understanding of IT infrastructure, including client server architecture, networks, and data backup/restore.
• Experience with both cloud-based and on premise software applications preferred.
• Proficiency in Microsoft Office Suite, Jira, and standard productivity tools; expert in Office and Excel.
• Effective time management and multi-tasking skills - able to keep an eye on the big picture outcome while managing day to day tasks and deadlines to meet key deliverables.
• Ability to effectively manage complex projects across multiple departments without direct supervision.
• Ability to work with a high level of detail and to a high standard.
• Strong oral, written communication and interpersonal skills are required; able to clearly and concisely deliver technical information.

Responsibilities

• Support Computerized System Validation (CSV) activities across various platforms, including Lab Information Management Systems (LIMS), Enterprise Resource Planning (ERP), Automation Programmable Logic Controller (PLC), Building Management Software (BMS), Manufacturing Execution Systems (MES), Product Lifecycle Management (PLM), Quality Management Systems (QMS), File Sharing Software, Calibration and Maintenance Management Systems (CMMS), and custom web applications.
• Ensure compliance to MSD quality management system (QMS) processes and procedures and adherence to 21 CFR Part 11, data integrity principles and Good Laboratory Practice/Good Clinical Laboratory Practice where applicable.
• Provide guidance to QA, IS/IT, and system owners on the elements pertaining to validation, and provide CSV training.
• Provide technical guidance on validation requirements for new and existing software to system owners.
• Author, review, and approve validation deliverables, including Requirements, Design Specifications, Validation Plans, Risk Assessments, Test Protocols, Validation Reports, Traceability Matrices, and Validation Change Orders.
• Execute validation protocols and provide objective evidence that system is compliant to applicable regulations and requirements.
• Review and Approve changes to validated systems: Interact with IS/IT, Quality, supporting departments, system owners and contractors to facilitate or perform validation activities.
• Document, review, approve, and resolve variances that occur.
• Compile and analyze submitted validation data for review and approval.
• Prepare and review completed and executed validation packages.
• Maintain list of validated computerized systems, related change control documentation, intended use and GxP impact to track software validations and upgrades.
• Conduct periodic reviews to ensure systems are maintained in a validated state during the course of the system operational phase.
• Maintain up-to-date knowledge of validation requirements, best practices, and procedures.
• Provide pertinent information to senior stakeholders and attend cross-functional team meetings as the subject matter expert.
• Represent and defend validation programs to client auditors and regulatory authorities.

Benefits

• Medical, dental, and vision coverage, along with prescription benefits.
• 401(k) plan with company matching.
• Flexible spending accounts.
• Company-paid short- and long-term disability insurance.
• Group life and accidental death and dismemberment insurance.
• Paid vacation, paid sick leave, paid holidays, and paid parental leave.
• Employee assistance program.
• Fitness club membership contribution.
• Pet insurance.
• Identity theft protection.
• Home and auto insurance discounts.
• Optional supplemental life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree