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