Sr Validation Engineer (TMV/Transfer) - Katalyst Healthcares & Life Sciences

• Perform tasks identified as part of the overall project plan including, but not limited to
  Planning, development, and implementation of analytical TMV-related documentation such as validation plans, validation protocols, completion reports, technical reports / memos, addenda, and statistical analyses, where applicable.

• Oversee the execution of analytical TMV and test method transfer work
  Assists in gathering data and documentation to be evaluated for overall analytical TMV strategy.

• Perform and support gap assessments for historical analytical TMV documentation (protocols, specifications, procedures, test methods, acceptance criteria, specifications, prior validation protocols and completion reports, etc.) and identify remedial action items based on the outcome of gap assessments and test method transfer / waivers.

• Evaluate, investigate, and document non-conformance incidents and deviations related to analytical TMV protocol execution.

• Perform test method transfer / waiver assessments and QC analytical test method documentation.

• Complete assigned remediation activities to ensure that all analytical TMV and test method transfers are conducted following the requirements of all policies and regulatory guidelines such as USP, ICH, and FDA.

• Provide training in any related analytical TMV documentation described herein, as applicable.

• Provide statistical analysis of data to support conclusions and develop statistical based sampling plans for in-process testing, final testing, and validations.

• Recommend method, process, and quality improvements as it relates to analytical TMV.

• Analyzes the results of executing analytical TMV protocols and determines the acceptability of results against predetermined acceptance criteria.

• Reports on project status and progress periodically to site management.

• Perform other related duties, as required.

• Education and Experience Required.

• B.S. in Chemistry, Engineering or other scientific-related discipline required (a B.S. in Chemistry / Analytical Chemistry is preferred).

• Minimum 5-7 years of experience in medical device and/or pharmaceutical manufacturing or quality control environment.

Requirements:

• Hands-on experience with methods utilizing DSC, Instron, spectrophotometers, HPLC, and other wet chemistry techniques.

• Must have the ability to independently develop and implement technical documentation related to analytical TMV and test method transfer / waiver.

• Must be able to interpret and apply industry standards (USP and ICH) as they relate to analytical method lifecycle management.

• Experience and practical knowledge of analytical TMV, test method transfer / waiver, quality, and/or validation engineering.

• Familiar with ISO 9001 and ISO 13485.

• Understanding of risk management as it relates to writing scientific justifications and rationale.

• Strong ability to solve technical issues utilizing an analytical approach to problem solving.

• Proficiency of statistics and interpreting data using statistical analysis software such as Minitab.

• Experience and familiarity with Gage R&R is a plus.

• Excellent organizational, oral, and written communication skills.

• Independently manage projects and track milestones.

• Proficient with MS Office (Excel, Word, PowerPoint, Outlook, Project, Teams).