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