This role is responsible for leading investigations to ensure that reports are technically sound, complete, and compliant with regulatory requirements. It also supports change management activities, including planning, documentation, and implementation, specifically related to GxP processes. The position operates cross-functionally, gathering relevant data and information to support investigations within Maintenance, Facilities, and Utilities (M2U). It will lead root cause analysis sessions with site subject matter experts (SMEs) and define corrective actions to prevent recurrence of deviations. As a key member of the M2U team, this individual will serve as a champion for quality, compliance, and operational excellence within the organization. This position reports directly to the M2U Compliance Engineering Manager.ResponsibilitiesDevelops 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 activitiesPresents 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.Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.Completes any other duties/responsibilities assigned by senior management.Education:Bachelor’s Degree in Engineering, Pharmaceutical Technology, or equivalent scientific degreeQualifications: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 industryExperience 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 reportProficient 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.Our BenefitsCSL 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 benefits site to see what’s available to you as a CSL employee.About CSL BehringCSL 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 CSL Behring.We want CSL to reflect the world around usAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.Do work that matters at CSL Behring!