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Validation Specialist

Company: Summit Biosciences Inc.
Location: Stanford
Posted on: February 25, 2021

Job Description:

Summary:The ideal candidate is responsible for performing and managing equipment, cleaning and process validation activities.--The job includes writing protocols, reports, compiling data and attachments into comprehensive validation packages. Additionally responsible for assisting with the development of procedures, specifications, validation master plans and other validation and engineering related documentation. May also participate in design, build activities, equipment procurement, optimization and troubleshooting of equipment and processes, hiring and development of staff.Essential Duties:-- Work on multiple validation projects simultaneously and coordinate test work-- Support coordination of all equipment qualification, cleaning and process validation activities and projects-- Write protocols for manufacturing, utilities, lab equipment and processes-- Execute validation work according to protocol instructions and procedures-- Plan, coordinate and track the progress of validation projects-- Compile validation packages and assure all required documentation is complete-- Identify and champion process improvement projects and ensure equipment and systems remain in a qualified state-- Assure compliance with quality policies and procedures related to validation activities-- Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure-- Work with QA and other groups to validate drug product manufacturing-- Writing, review and approval of technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents-- Train personnel to write, execute and summarize studies and oversees work-- Perform qualification activities under ISPE, GAMP, and ICH guidelines-- Support maintenance activities including review/approval of preventative maintenance tasks, calibration, drawing updates, related investigations-- Lead risk assessment exercises related to equipment and processes (FMEA, VSM, etc)-- Maintain strict deadlines to minimize impact to production and maximize equipment/process efficiency-- Participate in equipment/process design, specification of use requirements and factory acceptance testing-- Other duties as assignedQualifications:-- BS in Biology, Chemistry, Engineering or related science or equivalent experience-- 2-5 years of validation experience in a cGMP manufacturing environment-- Excellent working knowledge of cGMPs and regulatory requirements is preferred-- Excellent technical writing and organizational skills-- Self-starting and multitasking-- Detail oriented-- Excellent organization and planning skills-- Strong communication and interpersonal skills-- Ability to change priorities in response to company demands while continuing to deliver results-- Strong work ethic; ability to excel in a fast paced, multiproduct environment-- Demonstrated ability to work/collaborate within teams while interfacing with both internal and external colleagues -- Ability to apply statistics and process capability methodologies to evaluate processes and to implement and monitor improvements-- Knowledge of calibration methodology, equipment, and instruments.-- Knowledge of software including:--CAD, Minitab, and Microsoft Office

Keywords: Summit Biosciences Inc., Lexington , Validation Specialist, Other , Stanford, Kentucky

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