Senior Validation Engineer Responsibilities: Develop Validation Documentation to support new / revised materials and suppliers for their associated process/product qualifications and provide support to existing business continuity and process improvement requirements.Work closely with key business partners including Source, R&D, Supplier Quality, Engineering, Operations, and Quality Assurance to deliver on business goals and objectives. Responsible for assuring compliance to applicable regulations and procedures while at the same time attaining operational effectivenessWork with the various departments/groups in development and execution of validation activities associated with new / revised materials and suppliersDesigns and develops validation documentation to support business continuity, new process introductionsImplementation and co-ordination of the change control process, promotes timely approval of all supporting documentationLeads and coordinates cross functional teams to drive business and organizational results for MSE's business continuity planning (BCP) projects.Supports raw materials complaint investigations and resolution of sameProvides assistance to other departments with trouble shooting problems, deviations, discrepancies and non-conformances.Support Regulatory Affairs with submissions to Regulatory bodies and associated enquiriesStrong technical writing skills and ability to present work clearly and with the appropriate content for the given audienceApply appropriate statistical and validation techniques based on overall riskApply a methodical approach in solving complex problems and in support of root cause analysis activities related to materials and associated processesEnsure all activities align with GMP, ISO, and quality system requirementsEnsure that all health, safety and environmental requirements are fulfilledQualifications: Minimum of a Bachelor's degree in a relevant engineering or science subject area (e.g. Chemical Engineering, Materials Science, Polymer Science) is required; Advanced degree (MS or PhD) is preferredMinimum of 3 - 5 years' experience in a Quality / Validation function within a regulated medical device, pharmaceutical, or consumer packaged goods industrySuccessful track record of project managementKnowledge of statistical design and analysis of experimentsExcellent written and oral communication skills requiredExcellent interpersonal skills requiredInternational collaboration experience is desired
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