Validation Engineer II

CSL Behring is a global leader in the protein bio therapeutics industry, focused on bringing to market bio therapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies.

Plans, communicates, and leads scientifically sound strategies for small to medium scale validation projects in a cGMP environment. Designs, schedules, and executes risk-based qualification/validation experiments which demonstrate compliance with regulatory requirements, product license restrictions, and industry standards under the guidance of the Validation Group Lead. Works closely with other department personnel as well as cross functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and R&D to achieve project deliverables. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. May represent the validation department on cross-functional and/or global project teams.

* Responsible for achieving department objectives/schedules while working across multiple departments regarding the qualification/validation of facilities, utilities, equipment, computers and process support. * Plans, communicates and leads scientifically sound qualification/validation strategies for small to medium scale projects. May assist in large scale projects as required. * Prepares validation project plans, protocols, and test equipment. Executes test protocols, collects and evaluates test data for conformance to acceptance criteria and/or to investigate and determine root cause of study discrepancies. * Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria. * Effectively communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to the needs and status of assigned study execution activities. * Recognizes and trouble shoots problems associated with validation studies, equipment, and procedures. * May serve as Subject Matter Expert (SME), reviewer, or approver of controlled documents within area(s) in of competency. * Researches governmental regulatory requirements and industry guidance on assigned projects * Assists the department in developing programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements. * Provides technical support/training to department personnel in areas of competency. Provides technical support other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed. * Supports the facility in internal and external inspections. * Able to enter into confined spaces (i.e. process tanks), as required. * Must be able to wear scrubs and meet cGMP gowning requirements to work in manufacturing environments. * Other tasks as required by Departmental Management.

**Position Qualifications and Experience Requirements** * BS in Chemical, Mechanical or Electrical Engineering, Physical or Biological Science with 3+ years qualification/validation related experience or Associates Degree with 6+ years specific qualification/validation experience. * Proven demonstration to perform in the role may also be considered. * Experience with the qualification/validation of facilities, utilities, equipment, computers, controls, and process support commercial manufacturing. * Experience with Manufacturing Execution Systems (MES) preferred. **Competencies:** * Priority setting * Planning * Time management * Approachability * Customer focus * Peer relationships * Patience * Negotiating * Composure * Listening * Action oriented * Perseverance * Drive for results * Written communications * Conflict management * Functional/technical skills * Technical learning * Dealing with ambiguity * Decision quality * Learning on the fly * Problem solving * Demonstrating CSL Values