Cleaning Validation Specialist
Boothwyn, PA, USA
Req #132
28 March 2024
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.
People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
The Role
- The Cleaning Validation Specialist is responsible for coordinating the cleaning validation activities , including but not limited to preparing and executing the protocols and reports for cleaning validation.
- This position will lead all efforts for cleaning method development and will work closely with Analytical Development team for executing the cleanability studies.
- This position will maintain the “Cleaning validation matrix” and will work with cross functional teams for introduction and assessment of new project.
- Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation.
- Perform investigation of deviations / discrepancies. Oversees and reviews validation area processes.
- Design and develop cleaning procedures for new products and manufacturing equipment.
- Provide technical support to cleaning activities associated with the manufacturing process.
- Lead the cleaning validation program and activities to keep up with manufacturing requirements and control cleaning related failures.
- Use of cleaning agents and the establishment of sound cleaning practices within new or refurbished manufacturing rooms and cleaning/sampling suites areas.
- Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.
- Investigates and conducts troubleshooting and root cause analysis of cleaning related incidents, deviations and CAPA. Complete Action items as assigned.
- Create, and review manufacturing cleaning Working Instructions, Standard Operating Procedures, Batch Records, Study Protocols and Cleaning Validation documentations.
- Supports the periodic review of cleaning validation studies.
- Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
- Trains manufacturing and QC/QA personnel on cleaning validation documentation.
- Perform cleanability studies and visible limit studies to determine the appropriate detergent and cleaning limits for new product development.
- Conduct data analysis in Minitab to draw conclusions for various cleaning studies.
- Conduct cleaning risk assessment on manufacturing equipment to determine difficult-to-clean surfaces and potential swab locations.
The Candidate
- Masters degree in a scientific field or an equivalent combination of education and experience.
- Minimum three (3) years of experience in Production or validation related field
- Competent in the use of Microsoft Office packages including Word, Excel, PowerPoint, Outlook.
- Experience and knowledge of within GMP regulated environment/department
- Experience and knowledge of statistical software like Minitab.
- Preferable experience of working in a Solid oral dose manufacturing environment or equivalent experience in another role.
Application Requirements
When applying for a position with Quotient Sciences you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
When applying for a position with Quotient Sciences you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
Other details
- Pay Type Salary
- Boothwyn, PA, USA