Sr Validation Engineer

Title: Sr Validation Engineer, Req#: ROCGJP00027216Location: Hillsboro, OR (100% onsite)Duration: 4+ months Contract (with the possibility of extension based on performance)Schedule: Monday - Friday and weekend on-call supportJob DescriptionThe Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV).Education And ExperienceBS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8 years with a BS (6 years with MS) experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is requiredExperience in the pharma/biotech industry is required.Experience with cleaning and sterilization validation is required.Candidate must demonstrate an understanding of cleaning and sterilization qualification requirements in the cGMP environment.Demonstrated project management skills.Experience authoring, reviewing, and executing validation protocols.Knowledge of cGMPs or equivalent regulations.Working knowledge of formulation, filling, and, packaging, equipment qualification in a regulated environment is required.Ability to work with internal teams, partners, suppliers and customers.Operational excellence and industrial engineering skills are a plus.Professional level written and oral communication skills.Key ResponsibilitiesDevelop and manage the detailed project plans and timelines for the execution of validation activities.Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.Lead the execution of CD/PQ/CV/PV/RV activities.Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts.Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.Provide input into investigations with potential validation impact.Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.Support the change management system for validated equipment, utilities, and facilities.Support the development of manufacturing documents as appropriate.TB_EN Job #: 24-12471