Computer System Validation Engineer II

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.

DUTIES AND RESPONSIBILITIES

• Support Computerized System Validation (CSV) activities across various platforms.
• 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.
• 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.
• Represent and defend validation programs to client auditors and regulatory authorities.

EXPERIENCE AND QUALIFICATIONS

• 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.
• 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.

KNOWLEDGE,

SKILLS AND ABILITIES

• 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.
• 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.

PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT

This is a hybrid position performed in a standard office environment, may additionally be performed in a suitable home office environment, and may spend time in a Low Particulate Room or BSL-1/BSL-2 laboratory environment as needed.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $78,100 to $116,200.

BENEFITS SUMMARY

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security.

EEO STATEMENT

MSD is an Equal Opportunity Employer.