Validation Engineer III / II
Atlanta, GA 30301
Validation Engineer III / II
The Validation Engineer III is responsible for providing a technically competent risk-based approach for the validation of manufacturing equipment, equipment cleaning procedures, manufacturing processes, and computer systems. The person in this position will be a project team member and have responsibility for identifying and communicating validation tasks, resource requirements and task durations for significant cross-functional projects.
The Validation Engineer III is responsible for the creation, review, execution, and approval of validation protocols, reports, review and assess vendor protocols and other relevant documentation. These documents can include, but not be limited to, change control, user requirements specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation, process validation (PPQ and CPV) and computer/automation validation in support of the equipment, utilities, facilities, products, processes and computer systems.
The position also requires the use of risk assessment tools for assessing validation requirements and the execution of periodic reviews where appropriate. This person will actively coordinate with Engineering, Product Development (PD), Manufacturing, Packaging, Regulatory Affairs, Quality Control and Quality Assurance to assure validation documentation is compliant with regulatory requirements and current industry practices.
- Planning and execution of significant cross-functional validation projects in support of equipment, utilities, facilities, product, process, computer system and cleaning validation.
- Write and review protocols and reports. Review and/or approval of change control.
- Perform and lead risk assessment exercises in support of validation activities and perform periodic reviews as needed.
- Collaborate with PD to ensure successful product development and technical transfer to Manufacturing.
- Coordinate validation activities including, but not limited to, protocol training, execution by validation and other departments, data collection, deviation resolution, and CAPA initiation, in support of assigned validation projects.
- Review and update validation SOPs.
- Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, utilities, facilities, product, process, computer system and cleaning validation.
- Validation representative on site project team and resource to other departments for product and process knowledge.
- Bachelor’s degree in Engineering or Science Field
Experience for Level III:
- Minimum of ten years relevant experience in pharmaceutical industry
- Minimum of 5 years of validation experience.
- Consistently demonstrated validation proficiency with knowledge consistent of an SME in cleaning validation, process validation, or computer/automation systems validation.
- Experienced in current validation trends and processes.
Experience for Level II
- Minimum of four years relevant experience in pharmaceutical industry
- Minimum of three years of validation experience.
- Consistently demonstrated validation proficiency with advanced knowledge in at least one area of validation: cleaning validation, process validation, and computer/automation systems.
- Experienced in current validation trends and processes