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Associate Director Validation

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$95,000 - $140,000
Job Type
Direct Hire
Bachelor of Science
Jan 01, 2017
Job ID
The Associate Director will manage and lead the Equipment Validation group within the Validation Technical Services Organization. The Associate Director is responsible for all activities associated with process equipment qualification, revalidation, computer qualification, SIP validation, and assisting with commissioning activities for the biopharmaceutical manufacturing facilty. Ensure qualification and validation activities meet internal and external compliance requirements. This position interacts with regulatory agencies during inspections and audits, and it may require minimal travel. •Manage Qualification, Validation, and Revalidation activities for the Equipment Validation group. Effectively and efficiently implement new systems, system upgrades, or system modifications. •Responsible for managing morale, productivity, and goals of direct reports. Maintain compliance with company policies. •Ensure activities within scope have proper Validation support, complete within established timelines, and are within budget. Work closely and collaboratively with cross functional groups and system owners. •Independently identify opportunities for continuous improvement. Provide technical solutions to validation issues and develop corrective action plans, as required. •Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes•Develop and implement validation policies. Maintain validation master plans, and ensure all activities performed in support of policies and master plans are compliant to current regulations. Provide support to regulatory inspections as the primary subject matter expert

Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.