Cleaning Validation

Woodstock, IL

Posted: 08/30/2019 Job Number: JN -082019-11084
Cleaning Validation Associate
8 am - 5 pm Monday-Friday, contract to hire role, paying up to 70/h.

Primary Responsibilities:
Generate and maintain cleaning validation master plan every year.
Proper sampling technique for swab and rinse samples (Demonstration through swab sampling certification program at the site is required after hire)
Sponsor change controls for SOPs and Batch Records to update cleaning process for current products
Act as Subject Matter Expert for cleaning validation and provide consultation to third party labs for test method development and method validation.
Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.
Closely work with Operations, Manufacturing Quality, Chemistry, New Product Development and third-party labs to coordinate cleaning validation execution, sample testing and data reporting.
Conduct risk assessment of existing and new processes/technology/ equipment and manage the impact of potential failure
Complete oversight of end to end process for protocol execution and closure

Requirements:
Must have pharmaceutical and solutions based background. Strong understanding of PDA/FDA regulations on cleaning validation. Prepare and execute protocols and reports for cleaning validation. Must have 3-5 years experience in cleaning validation.
Education Requirements: B.S. degree required, preferably in chemical engineering or chemistry Experience Requirements: Must have 3-5 years Cleaning Validation in Pharmaceutical
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