Validation Specialist

Engineer, Cleaning Validation Specialist3 Key Consulting is hiring an Engineer, Cleaning Validation Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:Our ideal candidate: 5+ YOE with a B.S. in Science, Engineering, and Pharmacy areas.This is a Cleaning Validation Specialist position. Candidate will coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studiesSupports non-traditional work schedule based on project and business needsFamiliar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV programDemonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.Proficient with KNEAT executionDesign and develop cleaning procedures for new products and manufacturing equipment.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.Supports the periodic review of cleaning validation studies.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.Why is the Position Open?Planned ProjectTop Must Have Skills:Proficient with KNEAT or similar programs.Strong understanding of GMPs and global regulatory expectations.Ability to interpret equipment design, P&IDs, and process flow diagrams.Excellent technical writing and documentation skills.Strong analytical and problem solving abilities.Effective communication and cross-functional collaboration.Ability to work independently and manage multiple priorities.Day to Day Responsibilities:Expectation is that the candidate will support execution and management of the CV lifecycle.Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studiesSupports non-traditional work schedule based on project and business needsFamiliar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV programDemonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.Proficient with KNEAT executionDesign and develop cleaning procedures for new products and manufacturing equipment.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.Supports the periodic review of cleaning validation studies.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.Basic Qualifications:Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experiencePreferred Qualifications:Project Management experience.Red Flags:Lack of experience on the floor or supporting field execution Inability to support non-traditional work scheduleInterview process:First round virtual screening 2nd round panel onsite.