Compliance Engineering Specialist

CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. The Compliance Engineering Specialist is responsible for leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This role is responsible for supporting the change planning, documentation, and implementation process as it relates to GxP activities.

This position will be responsible for operating cross-functionally, collecting necessary data and information associated with M2U (Maintenance, Facilities, and Utilities) investigations. This position will lead root cause analysis sessions with site SME’s and determine the associated corrective action to prevent the deviation from recurring.

This person will be a key player in the M2U team and a champion for quality priority principles and compliance within the M2U organization.
This position reports directly to the M2U Compliance Engineering Manager

Responsibilities
 Develops a comprehensive understanding of the manufacturing processes followed for CSL products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
 Provides consistent direction and ensures timely completion of deviation investigations and change control implementation to ensure on-going consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with M2U, Manufacturing Value Streams and Quality teams.
 Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems.
 The compliance engineering specialist will support in the change planning, documentation, and implementation process as it relates to GxP activities
 Presents all applicable changes to Change Review Board (CRB) with the support of the subject matter expert (SME).
 Manages Change Request Intake to monitor all incoming new changes requested by subject matter experts (SME).
 The compliance engineering specialist will lead the investigation of deviations that occur in M2U. Author and manage the investigations to meet key timing commitments, with well investigated and well-documented deviation reports.
 Partners with quality assurance, quality control, operations, engineering, maintenance, calibration, and safety management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions.
 Determines scope, product impact, root cause and corrective actions for deviations from procedures. Proposes and implements effective CAPA to eliminate these causes.
 Determines appropriate preventative actions to prevent reoccurrence of the deviation, authors deviations and conducts personnel interviews to determine the root cause of the deviation.
 Update SOPs or other official documents as required.
 Support managing M2U CAPA’s for CAPA completion and new CAPA’s entered on master list.

Education:
 Bachelor’s Degree in Engineering, Pharmaceutical Technology, or equivalent scientific degree

Qualifications:
 3+ years of experience in a cGMP regulated manufacturing pharmaceutical environment and/or QA/QC, preferred.
 3+ years of technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry
 Experience with change management.
 Strong presentation skills preferred.
 Relevant industry Biotechnology Manufacturing and/or Quality operations experience.
 Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents.
 Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report
 Proficient in Quality Management Systems (i.e. TrackWise, Veeva).
 Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment.
 Proficient in the use of the following methodology: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction.

The expected base salary range for this position at hiring is $88,000 - $105,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addi