Validation Engineer Senior

Fully onsite - 8-5 Monday - Friday - occasional availability needed outside normal hours such as nights or weekends.

Ideal candidate: 8+ YOE Must have field execution experience.

• Lead the execution of all Cleaning Validation activities (CV/SIP PQ/CHT/SHT studies), including protocol generation, field execution, data retrieval/verification, sample management following a Lifecycle Approach and using Kneat.
• Supports non-traditional work schedule based on project and business needs
• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• 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.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.
• Support the development of the periodic cleaning monitoring program.
• Benchmark against the broader Client network and external industry with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network to achieve excellence in Cleaning Validation.
• Support assigned teams as required to provide Cleaning Validation guidance.
• Review and coordinate Change Controls with Cleaning Validation impact as required.
• Lead and support continuous improvement by identifying and implementing projects to eliminate waste and improve cleaning times through CIP Optimization.
• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures