Cleaning Validation Engineer

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