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 :
- 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
Cleaning Validation Engineer
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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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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