Roles & Responsibilities :
Lead or support cleaning, equipment, sterilization and autoclave qualifications
Ensure the timely completion of cleaning monitoring as well as validation team assignments.
Provide swab, rinse and visual inspection for cleaning validation sampling
Perform temperature mapping for CTU and SIP
Author and review qualification protocols, engineering change orders, SOP changes, engineering commissioning and turnover packages.
Review planned / unplanned events and provide initial assessment for validation lead.
Review of lifecycle documents for migration into new electronic system
Responsible for on-time completion of validation activities according to the overall current manufacturing schedule.
Ensure coordination of validation requirements with Quality, Manufacturing & Engineering.
Education & Experience :
7+ years of relevant validation engineer experience
BA / BS in Engineering or Life Sciences
Experience in cleaning validation sampling (swab, rinse and visual inspection)
Have experience with autoclave qualification
Have experience performing temperature mapping for CTU and SIP
Have the ability to coordinate with other groups for sample timing,
Experience using electronic systems for document management
Establish and maintain good relationships with various site functional groups as well as external validation contractors and consultants.
Ability to manage and track validation progress in required detail with data basis and
schedules.
Excellent teamwork skills communication and problem-solving skills
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Ensure the timely completion of cleaning monitoring as well as validation team assignments. Provide swab, rinse and visual inspection for cleaning validation sampling. Author and review qualification protocols, engineering change orders, SOP changes, engineering commissioning and turnover packages. ...
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