Associate Director, Cleaning Validation and Contamination Control Expert

As the Associate Director, Cleaning Validation and Contamination Control Expert, you will be the primary accountable for setting up technical expectation for the site contamination control and cleaning validation strategies that are agile and adequate.

You will be accountable for establishing improved cleaning validation and contamination control strategy, maintain them and provide support to site investigations through complex issues and challenges related to microbial contamination. You will work in a highly cross-functional matrix environment and will work closely with cleaning validation and contamination control counterparts in quality and engineering organizations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Establish requirements for cleaning validation, provides in depth technical support to resolve challenges related to cleaning validation
• Represents site at CoP and Task Forces
• Facilitate, lead and/or participate on risk assessments and contamination and cleaning validation investigation and ensure well written investigation reports
• Advance Contamination Control and Cleaning Validation Program goals and drive sites related governance meetings
• Serve as the point of contact for inspection readiness with respect to contamination control and cleaning validation activities
• Support new product transfers as the contamination control expert, new process and equipment design for microbial control, and microbial risk assessments for new products and processes
• Support cross-contamination programs and initiatives across the GSC supply chain including the setting of standards within the QMS

We are looking for professionals with these required skills to achieve our goals:

• Bachelors degree
• 15+ years of industrial experience in biopharmaceutical process development, MSAT or CMC roles
• Experience with current trends in the industry for cleaning validation and contamination control, ICH Guidelines and GMP principles at commercial scale
• Experience in Contamination Control and prevention methods
• Prior experience with cleaning validation programs for DS manufacturing processes at commercial scale
• Experience with large scale stainless steel commercial bioprocesses

If you have the following characteristics, it would be a plus:

• Strong interpersonal and leadership skills
• Able to interact well cross-functionally within the site and with multiple stakeholders out of the sites, in and out of GSC organization (GRA, global compliance etc.)
• Strong verbal and presentation communication skills which emphasize teamwork with a strong quality orientation
• Strong capability to prioritize effectively and deploy resources to ensure prompt resolutions to day-to-day issues
• Thorough understanding of bioprocesses for DS manufacturing

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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