Regional Sterilty Assurance US

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Regional Sterility Assurance? This is a hybrid role in our Kankakee IL or Holly Springs NC office. You will report to the Head of Enterprise Sterility Assurance.

You will manage the leadership, oversight and life cycle management for the contamination control governance elements including Sterility Assurance concept pillars, validation controls and monitoring controls at the region-based CSL manufacturing and routine partners CMOs sites. The scope is applying to both sterile steps as we bioburden-controlled steps of the manufacturing processes.

You partner with Sterility Assurance Enterprise Heads of Sterility Assurance Systems & Standards and CMOs Strategy to develop the CSL Sterility Assurance processes in both dimensions of monitoring and validation of the Enterprise core Sterility Assurance activities, perform global regulatory for changes and perform external advocacy and benchmark

You are responsible for routine Sterility Assurance oversight of CMOs for the region (if applicable) including accountability in the oversight of Sterility Assurance deviations, improvement plans, audits and any routine business activities to better support of CSL functions partnering with the CMOs such as ESQ and ESI

Responsibilities:

• You specifically maintain the Annex1 gaps mitigation and CAPEX-driven remediation

• Use knowledge of the facility, process and equipment to design the validation controls on an aseptic facility applicable to the core Sterility Assurance activities (i.e. aseptic media fill simulation program)

• Responsibility for the site’s inspection readiness and in responding to inspection observations relating to sterility assurance.

• Generate the documentation (IQ/OQ/PQ documents, SOPs, risk assessments in the areas relating to sterility assurance, ensure compliance to GMP and that required standards are met.

• Bachelor's Degree in Microbiology/biology life sciences.

• 8+ years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing

• 3+ years of experience in the manufacturing of biologics

• Professional experience leading teams for aseptic cleanrooms, process, equipment, consumables and utilities, validation and microbiological monitoring

• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.

  Benefits

• Medical, Dental, Vision

• 401K

• PTO

#LI-Hybrid

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about .

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL.