The Staff Validation Engineer (CSV) will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV) and Lifecycle procedures, and Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems. The incumbent will provide the necessary oversight of system related issues, employ risk-based methodology, and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Additionally, the individual will focus on ensuring consistent policy administration, implementing key improvement initiatives and solving compliance issues.

Key Areas of Accountability / Responsibility

1. Serve as a principle technical expert in regards to validation activities associated with equipment, computers, and processes.

2. Serve as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.

3. Lead multiple complex validation activities associated with computers, equipment, and processes.

4. Develop and execute validation plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs.

5. Coordinate validation associated audit activities; establish rationales and technical defense positions.

6. Negotiate with clients the validation requirements for projects. Resolve significant validation, product and regulatory issues. Plan and establish technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.

7. Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.

8. Participate as the validation representative in project team activities and process design to insure CGMP compliance and interdepartmental consistency within the validation program.

9. Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.

10. Maintain current knowledge and serve as a technical resource for emerging trends and technologies.

11. Coordinate and provide training and/or opportunities for career development of others.

12. Perform other duties as assigned.

Required level of experiences

BS/BA in a scientific or production related discipline plus 6 years experience in the pharmaceutical industry to include 2 years validation experience.

AA/AS in a scientific or production related discipline plus 7 years experience in the pharmaceutical industry to include 2 years validation experience.

8 years experience including 2 years validation experience.

Broad based knowledge of regulatory compliance requirements related to validation and relevant production controls.

Strong interpersonal and communication skills. Ability to effectively collaborate with others to achieve team goals and expectations.