Validation Scientist II','31724','!*! Plans, communicates, and leads scientifically sound strategies for small to medium scale validation projects in a cGMP environment. Designs, schedule, and execute scientifically sound 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 validation 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. Role that this position reports to: Group Lead Validation Role/s that report to this position: N/A Main Responsibilities and Accountabilities:
1) Responsible for achieving department objectives/schedules while working across multiple departments. 2) Plans, communicates and leads scientifically sound validation strategies for small to medium scale validation projects. May assist in large scale projects as required.
3) Prepares validation project plans, protocols, and test equipment for execution. Collects and evaluates validation test data for conformance to protocol acceptance criteria and/or to investigate and determine root cause of validation study discrepancies 4) Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria.
5) 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 6) Recognizes and trouble shoots problems associated with validation studies, equipment, and procedures.
7) May serve as Subject Matter Expert (SME), reviewer, or approver of controlled documents within area(s) in of competency
8) 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.
9) Provides technical support/training to Validation department personnel in areas of competency. Provides technical support other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed. 10) Supports the facility in internal and external inspections.
11) Other tasks as required by Departmental Management.
','!*! Position Qualifications and Experience Requirements: Education & Experience
BS in Engineering, Physical or Biological Science with 3 years validation related experience or Associates Degree with 6 years specific validation experience. Proven demonstration to perform in the role may also be considered.Experience with current US and international regulations, industry guidance and best-practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing.
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.
','Quality','United States-Illinois-Kankakee','','CSL Behring LLC Kankakee','Ongoing','Validation Scientist II
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