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Cleaning Validation Engineer is responsible for the execution of cleaning validation activities at the Active Pharmaceutical Ingredient (API) manufacturing sites of Agilent Technologies Nucleic Acid Solutions Division. Generating and executing validation study documentation including protocols, cycle development notebook studies, final reports, deviations, and SOPs while ensuring compliance with cGMP requirements.
Essential duties and responsibilities
- Designs and develops cleaning procedures for new products and manufacturing equipment
- Provide technical support to cleaning activities associated with the manufacturing process
- Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.
- Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures
- Leads the enhancement of cleaning practices, "clean in place" equipment and introduction
- Works cross-functionally to ensure adherence to cleaning program documentation and site initiatives
- Represents cleaning program in client and regulatory audits
- Develops technical and manufacturing documents necessary for development studies, cleaning validation, and post-validation process verification, in alignment with corporate and industry standards
- Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at root cause
- Maintains alignment with internal technical personnel regarding validation practices for products, processes and equipment
- Partners with cross-functional areas on validation study implementation
- Assists with validation planning and risk assessments associated with validation activities.
- Resolves CAPA's, nonconformances, protocol incidents, and change controls related to validation protocols.
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to read, analyze and interpret common scientific and technical journals. Ability to communicate to a group of individuals through oral and/ or written materials.
- Knowledge of pharmaceutical manufacturing processes, quality improvements, and efficiency.
- Strong writing ability required. Knowledge in the fields of Science and Engineering with the ability to apply these concepts to define problems, collect data, establish facts, take care of concrete and abstract variables and draw valid conclusions.
- Ability to use advanced mathematical concepts to problem analysis and resolution utilizing correlation techniques, frequency distribution, permutations, and factor analysis.
- Ability to coordinate multiple tasks and priorities and establish short and long-term planning horizons to complete these duties.
- Ability to work as a team to meet goals and objectives yet make independent decisions on various tasks.
- Knowledge of cGMP guidelines as well as international regulations pertaining to the production of APIs and drug products.
- Knowledge of and ongoing technical competence and engagement in the field of Cleaning Validation.