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Validation Specialist IV
Ref No.: 18-11504
Location: Swiftwater, Pennsylvania
Support the development of validation strategy, including preparation of key documentation such as risk assessments, protocols and validation project plans
Gather and analyze information and data from regulations, industry practices, vendors, guidelines, procedures, historical reports, and existing manufacturing facilities on site, in order to design and support transfer and implementation of process in new facility
Design and execute engineering runs / process studies / equipment performance qualification / integrated functional testing, collate results and perform data analysis, interpret data, & draw conclusions. Document and interpret study results providing recommendations back to project team and Sanofi Pasteur management.
Troubleshoot and identify corrective actions for issues and deviations on process and equipment systems
Interface with suppliers and vendors to gather and interpret technical information provided to Sanofi Pasteur in order to assess for impact to manufacturing process, as well as recommend validation strategies as a result of that information
Participate on cross-functional project teams in the planning and execution of project deliverables including engineering, investigational, or validation runs as required
Manage project timelines to ensure deliverables are met on time and on budget
Project work must be conducted independently with direction and oversight from the area technical lead, and requires successful application of scientific and engineering problem solving skills. The candidate will also be required to obtain a basic working knowledge of company-specific systems, standards, and procedures. Periodic checks and reports are required to review soundness of technical judgment and the status / schedule of the effort.

Required Qualifications:
Experience with performance qualification (PQ) and / or process validation (PV / PPQ)
Demonstrated interpersonal skill, including flexibility and ability to work in a team environment
Proven analytical abilities, including ability to perform basic statistics
Demonstrated written and verbal communication skills
Ability to work both independently and as part of a project team collaborating with members from Manufacturing/Operations, Manufacturing Technology, Validation, Automation and Quality
Demonstrated technical problem-solving, communication, and collaboration skills
Demonstrated organization skills, ability to multitask, and work in a dynamic environment
Preferred Experience:
Experience with facility start-up and engineering runs
Experience with MS Visio, MS Project, Visual Basic, and DeltaV
Good understanding of basic lab skills including aseptic technique, proper usage of measuring apparatuses, biosafety cabinet usage, etc.