The CSV Validation Engineer III will write and assist in writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices. Interact with CSV Management to prioritize and/or harmonize activities. Participate in multi-site CSV initiatives through document development or other validation activities. The CSV Validation Engineer III will review, generate system assessments, test scripts, change controls, process improvements and compliance governance at all applicable points of the system life cycle. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes.
- Generate, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation.
- Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
- Execute protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated to validated computer systems
- Perform Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
- Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.
- Performs periodic reviews and ongoing support of validated systems post Go-Live.
- Perform revalidation and change control validation related activities.
- Ability to apply complex system validation principles to work assignments.
- Responsible for executing and reviewing control systems validation activities including projects associated with PCS, BMS, CMS, OSI PI, and other automation upgrades.
- Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
- Provide training to colleagues and contractors on our approach to systems implementation and validation SOP's.
- Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering.
- Develop and maintain Validation SOPs, forms, documentation and files.
EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE
- Five plus (5+) years of relevant automation, engineering, project management or operations experience within a cGMP environment, with at least 3 years of recent automation experience.
- Computer systems experience with or for manufacturing, equipment and process, as well as utilities, and facilities qualification.
- Experience in the biotechnology and/medical or pharmaceutical industry. Proficiency of Computers Systems Validation and Quality Systems.
- Good knowledge and skills in engineering of Automation for HVAC/ Clean Media / Process Utility/Monitoring Building Management Systems including system
- GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP
- Experience in thorough testing of applications, computerized systems, changes and implementations.
- Excellent written and oral communication to include accurate and legible documentation skills.
- Ability to work in a fast-paced environment.
- Team oriented.
- Independent work skills and a strong work ethic.
- Microsoft Office and database management skills.
- Ability to handle multiple projects
PHYSICAL REQUIREMENTS -
- Must be able to sit or stand for prolonged periods of time
- Must be able to travel between production facilities
COMMUNICATIONS & CONTACTS
Interacts with all departmental staff and other departments at all levels.
- Ability to interface and communicate directly with clients may be required.